Document And Entity Information
Document And Entity Information - shares | 3 Months Ended | |
Mar. 31, 2021 | May 17, 2021 | |
Cover [Abstract] | ||
Entity Registrant Name | INVO Bioscience, Inc. | |
Entity Central Index Key | 0001417926 | |
Document Type | 10-Q | |
Document Period End Date | Mar. 31, 2021 | |
Amendment Flag | false | |
Current Fiscal Year End Date | --12-31 | |
Entity Current Reporting Status | Yes | |
Entity Interactive Data Current | Yes | |
Entity Filer Category | Non-accelerated Filer | |
Entity Small Business | true | |
Entity Emerging Growth Company | false | |
Entity Shell Company | false | |
Entity Common Stock, Shares Outstanding | 10,499,035 | |
Document Fiscal Period Focus | Q1 | |
Document Fiscal Year Focus | 2021 |
Condensed Consolidated Balance
Condensed Consolidated Balance Sheets - USD ($) | Mar. 31, 2021 | Dec. 31, 2020 |
Current assets | ||
Cash | $ 8,423,236 | $ 10,097,760 |
Accounts receivable | 527,651 | 21,699 |
Inventory | 268,349 | 265,372 |
Prepaid expenses and other current assets | 363,969 | 157,700 |
Total current assets | 9,583,205 | 10,542,531 |
Property and equipment, net | 129,679 | 132,206 |
Capitalized patents, net | 22,606 | 5,427 |
Lease right of use | 73,644 | 79,319 |
Trademarks | 100,885 | 89,536 |
Notes receivable | 280,160 | |
Other assets | 240 | |
Investment in joint ventures | 98,084 | |
Total other assets | 477,295 | 272,606 |
Total assets | 10,190,179 | 10,947,343 |
Current liabilities | ||
Accounts payable and accrued liabilities, including related parties | 512,044 | 328,927 |
Accrued compensation - related party | 267,390 | 527,326 |
Deferred revenue, current portion | 714,286 | 714,286 |
Lease liability, current portion | 23,061 | 22,707 |
Notes payable - Payroll Protection Program | 157,620 | 157,620 |
Convertible notes, net | 185,458 | 536,063 |
Income taxes payable | 1,062 | |
Total current liabilities | 1,859,859 | 2,287,991 |
Lease liability, net of current portion | 52,789 | 58,634 |
Deferred revenue, net of current portion | 2,678,571 | 2,857,143 |
Deferred tax liability | 469 | 469 |
Total liabilities | 4,591,688 | 5,204,237 |
Stockholders' equity | ||
Common Stock, $.0001 par value; 125,000,000 shares authorized; 10,424,229 and 9,639,268 issued and outstanding as of March 31, 2021 and December 31, 2020, respectively | 1,042 | 964 |
Additional paid-in capital | 40,287,000 | 37,978,224 |
Accumulated deficit | (34,689,551) | (32,236,082) |
Total stockholders' equity | 5,598,491 | 5,743,106 |
Total liabilities and stockholders' equity | $ 10,190,179 | $ 10,947,343 |
Condensed Consolidated Balanc_2
Condensed Consolidated Balance Sheets (Parenthetical) - $ / shares | Mar. 31, 2021 | Dec. 31, 2020 |
Statement of Financial Position [Abstract] | ||
Common stock, par value | $ .0001 | $ .0001 |
Common stock, shares authorized | 125,000,000 | 125,000,000 |
Common stock, shares issued | 10,424,229 | 9,639,268 |
Common stock, shares outstanding | 10,424,229 | 9,639,268 |
Condensed Consolidated Statemen
Condensed Consolidated Statements of Operations (Unaudited) - USD ($) | 3 Months Ended | |
Mar. 31, 2021 | Mar. 31, 2020 | |
Total revenue | $ 684,523 | $ 258,571 |
Cost of goods sold: | ||
Production costs | 60,314 | 27,563 |
Depreciation | 2,431 | 2,431 |
Total cost of goods sold | 62,745 | 29,994 |
Gross profit | 621,778 | 228,577 |
Selling, general and administrative expenses | 2,115,303 | 1,595,046 |
Research and development expenses | 66,267 | 30,050 |
Total operating expenses | 2,181,570 | 1,625,096 |
Loss from operations | (1,559,792) | (1,396,519) |
Other income (expense): | ||
Interest income | 2,013 | |
Interest expense | (895,226) | (47,873) |
Foreign currency exchange loss | (464) | |
Total other expenses | (893,677) | (47,873) |
Loss before income taxes | (2,453,469) | (1,444,392) |
Provision for income taxes | ||
Net loss | $ (2,453,469) | $ (1,444,392) |
Net loss per common share basic | $ (.25) | $ (0.29) |
Net loss per common share diluted | $ (.25) | $ (0.29) |
Weighted average number of common shares outstanding basic | 9,888,025 | 4,917,997 |
Weighted average number of common shares outstanding diluted | 9,888,025 | 4,917,997 |
Product revenue [Member] | ||
Total revenue | $ 505,952 | $ 80,000 |
License Revenue [Member] | ||
Total revenue | $ 178,571 | $ 178,571 |
Condensed Consolidated Statem_2
Condensed Consolidated Statements of Stockholders' Equity (Deficiency) (Unaudited) - USD ($) | Common Stock [Member] | Additional Paid-In Capital [Member] | Accumulated Deficit [Member] | Total |
Beginning balance at Dec. 31, 2019 | $ 489 | $ 20,174,682 | $ (23,888,766) | $ (3,713,595) |
Beginning balance, shares at Dec. 31, 2019 | 4,884,879 | |||
Common stock issued to directors and employees | $ 4 | 303,459 | 303,463 | |
Common stock issued to directors and employees, shares | 40,569 | |||
Common stock issued for services | 38,000 | 38,000 | ||
Common stock issued for services, shares | 5,000 | |||
Stock options issued to employees | 381,475 | 381,475 | ||
Net loss | (1,444,392) | (1,444,392) | ||
Ending balance at Mar. 31, 2020 | $ 493 | 20,897,616 | (25,333,158) | (4,435,049) |
Ending balance, shares at Mar. 31, 2020 | 4,930,448 | |||
Beginning balance at Dec. 31, 2020 | $ 964 | 37,978,224 | (32,236,082) | 5,743,106 |
Beginning balance, shares at Dec. 31, 2020 | 9,639,268 | |||
Common stock issued to directors and employees | $ 3 | 97,450 | 97,453 | |
Common stock issued to directors and employees, shares | 30,000 | |||
Common stock issued for services | $ 7 | 221,243 | 221,250 | |
Common stock issued for services, shares | 71,500 | |||
Conversion of notes payable and accrued interest | $ 39 | 1,243,749 | 1,243,788 | |
Conversion of notes payable and accrued interest, shares | 388,684 | |||
Proceeds from warrant exercise | $ 4 | 123,558 | 123,562 | |
Proceeds from warrant exercise, shares | 39,095 | |||
Proceeds from unit purchase option exercise | $ 8 | 246,270 | $ 246,278 | |
Proceeds from unit purchase option exercise, shares | 77,444 | |||
Cashless warrant exercise | $ 9 | (9) | ||
Cashless warrant exercise, shares | 91,709 | |||
Cashless unit purchase option exercise | $ 8 | (8) | ||
Cashless unit purchase option exercise, shares | 86,529 | |||
Stock options issued to directors and employees as compensation | 376,523 | 376,523 | ||
Stock options issued to employees | ||||
Net loss | (2,453,469) | (2,453,469) | ||
Ending balance at Mar. 31, 2021 | $ 1,042 | $ 40,287,000 | $ (34,689,551) | $ 5,598,491 |
Ending balance, shares at Mar. 31, 2021 | 10,424,229 |
Condensed Consolidated Statem_3
Condensed Consolidated Statements of Cash Flows (Unaudited) - USD ($) | 3 Months Ended | |
Mar. 31, 2021 | Mar. 31, 2020 | |
Cash flows from operating activities: | ||
Net loss | $ (2,453,469) | $ (1,444,392) |
Adjustments to reconcile net loss to net cash (used in) provided by operating activities: | ||
Non-cash stock compensation issued for services | 94,611 | 38,000 |
Non-cash stock compensation issued to employees | 97,453 | 303,463 |
Fair value of stock options issued to employees | 376,523 | 381,475 |
Amortization of discount on notes payable | 860,155 | 39,918 |
Amortization of leasehold right of use asset | 5,675 | 5,529 |
Depreciation and amortization | 2,979 | 2,980 |
Changes in assets and liabilities: | ||
Accounts receivable | (505,952) | 3,859 |
Interest receivable | (160) | |
Inventory | (2,977) | (60,896) |
Prepaid expenses and other current assets | 18,694 | 22,675 |
Accounts payable and accrued expenses | 183,117 | (76,791) |
Accrued compensation | (259,936) | 94,144 |
Deferred revenue | (178,572) | (178,572) |
Leasehold liability | (5,491) | (5,163) |
Accrued interest | 33,028 | 10,321 |
Income taxes payable | (1,062) | |
Net cash used in operating activities | (1,735,384) | (863,450) |
Cash from investing activities: | ||
Payments to acquire property, plant and equipment | (20,528) | |
Payments to acquire intangible assets | ||
Payment for notes receivable | (280,000) | |
Net cash used in investing activities | (308,980) | (25,135) |
Cash from financing activities: | ||
Proceeds from warrant exercise | 123,562 | |
Proceeds from unit purchase option exercise | 246,278 | |
Net cash provided by financing activities | 369,840 | |
Decrease in cash and cash equivalents | (1,674,524) | (888,585) |
Cash and cash equivalents at beginning of period | 10,097,760 | 1,238,585 |
Cash and cash equivalents at end of period | 8,423,236 | 350,000 |
Supplemental disclosure of cash flow information: | ||
Cash paid during the period for: Interest | 2,043 | |
Cash paid during the period for: Taxes | 912 | |
Non cash activities: | ||
Common stock issued upon note payable and accrued interest conversion | 1,243,788 | |
Common stock issued for prepaid services | 168,850 | |
Cashless exercise of warrants | 9 | |
Cashless exercise of unit purchase options | 8 | |
Patents [Member] | ||
Cash from investing activities: | ||
Payments to acquire intangible assets | (17,631) | |
Trademarks [Member] | ||
Cash from investing activities: | ||
Payments to acquire intangible assets | $ (11,349) | $ (4,607) |
Description of Business
Description of Business | 3 Months Ended |
Mar. 31, 2021 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
Description of Business | Note 1 – Description of Business INVO Bioscience (“INVO” or the “Company”) is a medical device company focused on the Assisted Reproductive Technology (“ART”) marketplace. The primary focus is the manufacture and sale of the INVOcell device and the INVO technology to provide an alternative infertility treatment for couples. The Company’s patented device, the INVOcell, is the first Intravaginal Culture (“IVC”) system in the world used for the natural in vivo incubation of eggs and sperm during fertilization and early embryo development (the “INVO Procedure”). INVOcell was granted clearance in the United States by the U.S. Food & Drug Administration (“FDA”) in November 2015, received the CE mark in October 2019, and is now positioned to help provide millions of infertile couples across the globe access to a new infertility treatment option. The Company believes this novel device and procedure provides a more natural, safe, effective, efficient and economical fertility treatment compared to current infertility treatments, including in-vitro fertilization (“IVF”) and intrauterine insemination (“IUI”). Unlike conventional infertility treatments such as IVF where the eggs and sperm develop into embryos in a laboratory incubator, the INVOcell utilizes the women’s vaginal cavity as an incubator to support a more natural fertilization and embryo development environment. This novel device promotes in vivo conception and early embryo development. In both current utilization of the INVOcell and in clinical studies, the INVO Procedure has proven to have equivalent pregnancy success and live birth rates as the traditional assisted reproductive technique, IVF. Additionally, the Company believes there are emotional benefits of the mother’s participation in the fertilization and early embryo development by vaginal incubation compared to that of conventional IVF treatment. INVOcell also offers to patients a more personalized way to achieve pregnancy. |
Summary of Significant Accounti
Summary of Significant Accounting Policies | 3 Months Ended |
Mar. 31, 2021 | |
Accounting Policies [Abstract] | |
Summary of Significant Accounting Policies | Note 2 – Summary of Significant Accounting Policies Basis of Presentation The accompanying consolidated balance sheets as of March 31, 2021 and December 31, 2020, the consolidated statements of operations and stockholders’ equity (deficiency) for the three months ended March 31, 2021 and 2020, and consolidated statement of cash flows for the three months ended March 31, 2021 and 2020 of the Company, and the related information contained in these notes have been prepared by management and are unaudited. In the opinion of management, all adjustments (which include normal recurring and nonrecurring items) necessary to present fairly the Company’s financial position, results of operations and cash flows in conformity with generally accepted accounting principles (“GAAP”) for the periods presented have been made. Interim operating results are not necessarily indicative of operating results for a full year. The accompanying consolidated financial statements present on a consolidated basis the accounts of the Company and its wholly owned subsidiaries. All significant intercompany accounts and transactions have been eliminated in consolidation. The preparation of the Company’s unaudited consolidated financial statements requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and the disclosure of contingent assets and liabilities at the date of the unaudited consolidated financial statements and the reported amounts of revenues and expenses during the reporting periods. Certain information and note disclosures normally included in the Company’s annual consolidated financial statements prepared in accordance with GAAP have been condensed or omitted. These unaudited consolidated financial statements should be read in conjunction with the consolidated financial statements and notes thereto included in the Company’s Annual Report on Form 10-K for the year ended December 31, 2020 previously filed by the Company with the Securities and Exchange Commission (“SEC”) on March 30, 2021. The Company considers events or transactions that have occurred after the unaudited consolidated balance sheet date of March 31, 2021, but prior to the filing of the unaudited consolidated financial statements with the SEC on this Quarterly Report on Form 10-Q, to provide additional evidence relative to certain estimates or to identify matters that require additional disclosure, as applicable. Subsequent events have been evaluated through the date of the filing of this Quarterly Report on Form 10-Q with the SEC. Cash and Cash Equivalents For financial statement presentation purposes, the Company considers time deposits, certificates of deposit and all highly liquid investments with original maturities of three months or less to be cash and cash equivalents. At times, cash and cash equivalents balances exceed amounts insured by the Federal Deposit Insurance Corporation. Inventory Inventories consist of raw materials, work in process and finished goods and are stated at the lower of cost or net realizable value, using the first-in, first-out (FIFO) method as a cost flow method. Property and Equipment The Company records property and equipment at cost. Property and equipment is depreciated using the straight-line method over the estimated economic lives of the assets, which are from 3 to 10 years. The Company capitalizes the expenditures for major renewals and improvements that extend the useful lives of property and equipment. Expenditures for maintenance and repairs are charged to expense as incurred. The Company reviews the carrying value of long-lived assets for impairment at least annually or whenever events or changes in circumstances indicate that the carrying amount of an asset may not be recoverable. Recoverability of long-lived assets is measured by a comparison of its carrying amount to the undiscounted cash flows that the asset or asset group is expected to generate. If such assets are considered impaired, the impairment to be recognized is measured by the amount by which the carrying amount of the property, if any, exceeds its fair market value. Stock Based Compensation The Company accounts for stock-based compensation under the provisions of Accounting Standards Codification (“ASC”) subtopic 718-10, Compensation (“ASC 718-10”). This statement requires the Company to measure the cost of employee services received in exchange for an award of equity instruments based on the grant-date fair value of the award. That cost is recognized over the period in which the employee is required to provide service or based on performance goals in exchange for the award, which is usually the vesting period. Loss Per Share Basic loss per share calculations are computed by dividing income (loss) available to common shareholders by the weighted-average number of common shares outstanding. Diluted earnings per share are computed similar to basic earnings per share except that the denominator is increased to include potentially dilutive securities. The Company’s diluted loss per share is the same as the basic loss per share for the three months ended March 31, 2021 and 2020, as the inclusion of any potential shares would have had an anti-dilutive effect due to the Company generating a loss. Three Months Ended March 31, 2021 2020 Loss to common shareholders (Numerator) $ (2,453,469 ) $ (1,444,392 ) Basic and diluted weighted-average number of common shares outstanding (Denominator) 9,888,025 4,917,997 The Company has excluded the following dilutive securities from the calculation of fully diluted shares outstanding because the result would have been anti-dilutive: Three Months Ended March 31, 2021 2020 Effect of dilutive common stock equivalents: Options 1,102,672 - Convertible notes and interest 160,504 - Unit purchase options and warrants 216,193 - Total 1,479,369 - Business Segments The Company operates in one segment and therefore segment information is not presented. Revenue Recognition The Company recognizes revenue on arrangements in accordance with ASC 606, Revenue from Contracts with Customers (“ASC 606”). The core principle of ASC 606 is to recognize revenues when promised goods or services are transferred to customers in an amount that reflects the consideration to which an entity expects to be entitled for those goods or services ASC 606 requires companies to assess their contracts to determine the timing and amount of revenue to recognize under the new revenue standard. The model has a five-step approach: 1. Identify the contract with the customer. 2. Identify the performance obligations in the contract. 3. Determine the total transaction price. 4. Allocate the total transaction price to each performance obligation in the contract. 5. Recognize as revenue when (or as) each performance obligation is satisfied. Revenues for products, including: INVOcell®, INVO TM Retention System, and INVO Microscope Holding Block are typically recognized at the time the product is shipped, at which time the title passes to the customer, and there are no further performance obligations. On November 12, 2018, the Company entered into a U.S. Distribution Agreement (the “Distribution Agreement”) with Ferring International Center S.A. (“Ferring”), pursuant to which it granted Ferring an exclusive license in the United States market only, with rights to sublicense under patents related to our proprietary intravaginal culture device (INVOcell™), together with the retention device and any other applicable accessories (collectively, the “Licensed Product”) to market, promote, distribute and sell the Licensed Product with respect to all therapeutic, prophylactic and diagnostic uses of medical devices or pharmaceutical products involving reproductive technology (including infertility treatment) in humans. The Ferring license was deemed to be a functional license that provide customers with a “right to access” to the Company’s intellectual property during the subscription period and accordingly, under ASC 606-10-55-60 revenue is recognized over a period of time, which is generally the subscription period. The initial upfront payment of $5,000,000 which was received upon the signing of the agreement is being recognized as income over the 7-year term. Long- Lived Assets Long-lived assets and certain identifiable assets related to those assets are periodically reviewed for impairment whenever circumstances and situations change such that there is an indication that the carrying amounts may not be recoverable. If the non-discounted future cash flows of the asset are less than their carrying amount, their carrying amounts are reduced to the fair value and an impairment loss recognized. There was no impairment recorded during the three months ended March 31, 2021 and 2020. Investment in Joint Ventures The following table sets forth a list of the Company’s current joint venture arrangements: Subsidiary Name Country Percent (%) Ownership HRCFG INVO, LLC United States 50% Positib Fertility, S.A. de C.V. Mexico 33% SNS MURNI INVO Bioscience Malaysia Sendirian Berhad Malaysia 50% Ginekalix INVO Bioscience LLC Skopje North Macedonia 50% Medesole INVO Bioscience India India 50% Alabama JV Agreement On March 10, 2021, the Company’s wholly owned subsidiary, INVO Centers, LLC (“INVO Centers”), entered into a limited liability company agreement (the “JV LLC Agreement”) with HRCFG, LLC (“HRCFG”) to form a joint venture for the purpose of commercializing INVOcell and the INVO Procedure at a dedicated fertility clinic in Birmingham, Alabama. The name of the joint venture LLC is HRCFG INVO, LLC (the “Alabama JV”). The responsibilities of HRCFG’s principals include providing clinical practice expertise, performing recruitment functions, providing all necessary training, and providing day-to-day management of the clinic. The responsibilities of INVO Centers will be to provide access to and be the exclusive provider to the Alabama JV of the INVOcell and the INVO Procedure. INVO Centers will also perform all required in vitro fertilization, industry specific compliance and accreditation functions, and product documentation for product registration. The Company will also provide certain funding to the Alabama JV. In connection with the formation of the Alabama JV, the Company provided an initial $30,000 in funding, in exchange for a note issued by HRCFG, which will be repaid from the operating profit of the Alabama JV. On March 19, 2021, the Company provided an additional $250,000 to HRCFG pursuant the note. Interest on the note accrues at a rate of 1.5% per annum. In addition, the Company has agreed to issue 25,000 shares of its common stock to HRCFG (i) upon opening the Birmingham clinic for business, and (ii) upon each additional INVOcell clinic opened for business by the Alabama JV. As of March 31, 2021, the Company had expended $64,932 in startup costs related to this joint venture. Mexico JV Agreement Effective September 24, 2020, INVO Centers, LLC entered into a Pre-Incorporation and Shareholders Agreement with Francisco Arredondo, MD PLLC (“Arredondo”) and Security Health LLC, a Texas limited liability company (“Ramirez”, and together with INVO and Arredondo, the “Shareholders”) under which the Shareholders will commercialize the INVO Procedure and offer related medical treatments in Mexico. Each party owns one-third of the Mexican incorporated company, Positib Fertility, S.A. de C.V. (the “Mexico JV”). The Mexico JV will acquire the INVOcell product at cost plus any incurred shipping, customs and related fees. The Mexico JV will operate in Monterrey Nuevo Leon, Mexico and any other cities and places in Mexico as approved by the Mexico JV’s board of directors and Shareholders. In addition, the Shareholders agreed that the Mexico JV will be the Company’s exclusive distributor in Mexico. The Shareholders also agreed not to compete directly or indirectly with the Mexico JV in Mexico. As of March 31, 2021, the Company had expended $51,670 in startup costs related to this joint venture. Malaysia JV Agreement On November 23, 2020, the Company entered into a joint venture agreement with SNS Murni SDN BHD (“SNS Murni”), a company incorporated in Malaysia, to establish an exclusive joint venture in Malaysia to (i) introduce, promote and market its technologies related to the INVOcell and INVO Procedure in dedicated government-owned fertility clinics in Malaysia, and (ii) establish INVO Clinics in Malaysia. The joint venture is co-managed and owned 50% by each of INVO Bioscience and SNS Murni. As of March 31, 2021, the Company has expended $7,885 in startup costs related to this joint venture. North Macedonia JV Agreement On November 23, 2020, the Company entered into a joint venture agreement with Ginekaliks Dooel (“Ginekaliks”), a limited liability company incorporated in the Republic of North Macedonia, to establish an exclusive joint venture to (i) commercialize, introduce, promote and market technologies related to the INVOcell and INVO Procedure in North Macedonia, (ii) establish a private healthcare institution to offer the INVO Procedure. The joint venture will be co-managed and owned 50% by each of INVO Bioscience and Ginekaliks. As of March 31, 2021, the Company had expended $2,597 in startup costs related to this joint venture. India JV Agreement On January 13, 2020, the Company entered into a joint venture agreement (the “Agreement”) with Medesole Healthcare and Trading Private Limited, India (“Medesole”), an Indian corporation that promotes and distributes healthcare technologies, medical equipment and allied services to hospitals, clinics and primary health care centers in India and the Middle East. Pursuant to the Agreement, the Company and Medesole have formed a joint venture entity incorporated and registered in India, which will operate under the name Medesole INVO Bioscience India Private Limited (the “India JV”). After formation, the Company will grant to the India JV all required licenses for promoting, marketing and selling the Company’s INVOcell® technology in India. The Company and Medesole intend that the India JV will open and operate dedicated INVOcell® clinics only in India. The India JV will be co-managed and owned 50% by each of INVO and Medesole, who will share equally in the expenditures, revenues and profits of the India JV. The Agreement has a term of three years and may be terminated by either party on 180 days’ prior written notice. Variable Interest Entities The Company’s consolidated financial statements include the accounts of the Company, its wholly owned subsidiaries and variable interest entities (“VIE’), where the Company is the primary beneficiary under the provisions of the ASC 810, Consolidation (“ASC 810”). Management makes judgments regarding the Company’s level of influence or control over an entity and whether or not the Company is the primary beneficiary of a VIE. Various factors are considered in this analysis, including but not limited to the Company’s ability to direct the activities that most significantly impact the entity’s governing body, the size and seniority of the Company’s investment, the Company’s ability and the rights of other investors to participate in policy making decisions, the Company’s ability to replace the manager and/or liquidate the entity, and the Company’s obligation to absorb losses and right to receive benefits that are significant. Management’s ability to correctly assess its influence or control over an entity when determining the primary beneficiary of a VIE affects the presentation of these entities in the Company’s consolidated financial statements. If it is determined that the Company is the primary beneficiary of a VIE, the Company’s financial statements would consolidate the VIE. The Company performs a qualitative assessment of its joint ventures on an ongoing basis to determine if it continues to be a primary beneficiary. The Company concluded it has a variable interest in the Alabama JV and the Mexico JV (the “JVs”) on the basis of its capital contributions to the JVs and the terms and conditions contained in the agreements that control the JVs. First, the Company determined that the JVs are VIEs, since the JVs’ equity at risk, as defined by GAAP, is considered to be insufficient to finance JV activities without additional support. Second, the Company determined that it has a controlling financial interest in, and thus is a primary beneficiary of the JVs. Such control stems from the Company’s power to direct activities that most significantly impact the JVs operations, and the Company’s obligation to absorb losses and its right to receive benefits from the JVs that would be significant to the JVs. Such power stems from the Company’s ability, among other things, to control the sale or transfer of the JVs capital units and/or common stock. As a result of its analysis, the Company concluded that it is a primary beneficiary of the JVs and therefore consolidates the balance sheets, results of operations and cash flows of the JVs into its own. As of March 31, 2021, there was no financial activity in the JV’s and therefore no impact on the Company’s financial statements. Recently Adopted Accounting Pronouncements None. |
Inventory
Inventory | 3 Months Ended |
Mar. 31, 2021 | |
Inventory Disclosure [Abstract] | |
Inventory | Note 3 – Inventory Components of inventory are: March 31, 2021 December 31, 2020 Raw materials $ 67,936 $ 72,022 Work in process 5,005 29,645 Finished goods 195,408 163,705 Total inventory $ 268,349 $ 265,372 |
Property and Equipment
Property and Equipment | 3 Months Ended |
Mar. 31, 2021 | |
Property, Plant and Equipment [Abstract] | |
Property and Equipment | Note 4 – Property and Equipment The estimated useful lives and accumulated depreciation for furniture, equipment and software are as follows as of March 31, 2021 and December 31, 2020: Estimated Useful Life Manufacturing equipment 6 to 10 years Medical equipment 10 years Office equipment 3 to 7 years March 31, 2021 December 31, 2020 Manufacturing equipment $ 132,513 $ 132,513 Medical equipment 49,261 49,261 Office equipment 2,689 2,689 Less: accumulated depreciation (54,784 ) (52,257 ) Total equipment, net $ 129,679 $ 132,206 During the three months ended March 31, 2021 and 2020, the Company recorded depreciation expense of $2,527 and $2,528, respectively. |
Patents and Trademarks
Patents and Trademarks | 3 Months Ended |
Mar. 31, 2021 | |
Goodwill and Intangible Assets Disclosure [Abstract] | |
Patents and Trademarks | Note 5 – Patents and Trademarks The Company capitalizes the initial expense related to establishing patents by country and then amortizes the expense over the life of the patent, typically 20 years. It then expenses annual filing fees to maintain the patents. The Company regularly reviews the value of its patents in the marketplace in proportion to the expense it must spend to maintain the patent. The Company has recorded the following patent costs: March 31, 2021 December 31, 2020 Patents $ 95,353 $ 77,722 Accumulated amortization (72,747 ) (72,295 ) Total patent costs, net $ 22,606 $ 5,427 During the three months ended March 31, 2021 and 2020, the Company recorded $452 and $452, respectively, of amortization expenses related to patents. The increase in the trademark assets of $11,349 was the result of additional legal fees. The trademarks have an indefinite life and therefore are not amortized. Trademarks are periodically reviewed for impairment whenever circumstances and situations change such that there is an indication that the carrying amounts may not be recoverable. The trademark assets were created in 2019, and no material adverse changes have occurred since their creation. |
Notes Receivable
Notes Receivable | 3 Months Ended |
Mar. 31, 2021 | |
Debt Disclosure [Abstract] | |
Notes Receivable | Note 6 – Notes Receivable On March 10, 2021, the Company entered into a promissory note with HRCFG, LLC, an unrelated party. The note was entered into in conjunction with the Alabama JV with HRCFG, LLC, accrues interest at 1.5% per annum and repayment of principal and interest shall be paid from 30% of HRCFG INVO LLC’s operating profit. The balance as of March 31, 2021 consists of $280,000 principle and $160 of accrued interest. The following table lists the Company’s notes receivable: March 31, 2021 December 31, 2020 Notes receivable – HRCFG, LLC $ 280,160 $ - Total notes receivable $ 280,160 $ - |
Leases
Leases | 3 Months Ended |
Mar. 31, 2021 | |
Lessee Disclosure [Abstract] | |
Leases | Note 7 – Leases The Company has an operating lease for its office, which has a remaining term of 5 years with an option to renew for three additional years. The lease does not have an early termination clause. The Company’s operating lease agreement does not contain any material restrictive covenants. Per FASB’s ASU 2016-02, Leases Topic 842 (“ASU 2016-02", effective January 1, 2019, the Company is required to report a right-of-use asset and corresponding liability to report the present value of the total least payments, with appropriate interest calculation. Per the terms of ASU 201-02, the Company can use its implicit interest rate, if known, or applicable federal rate otherwise. Since the Company’s implicit interest rate was not readily determinable, the Company utilized the applicable federal rate, which was 3.0% as of April 2019. As of March 31, 2021, the Company’s lease components included in the consolidated balance sheet were as follows: Lease component Balance sheet classification March 31, 2021 Assets ROU assets - operating lease Other assets $ 73,644 Total ROU assets $ 73,644 Liabilities Current operating lease liability Current liabilities $ 23,061 Long-term operating lease liability Other liabilities 52,789 Total lease liabilities $ 75,850 Future minimum lease payments under non-cancellable leases were as follows: March 31, 2021 2021 $ 18,751 2022 25,585 2023 26,352 2024 8,870 2025 and beyond - Total future minimum lease payments $ 79,558 Less: Interest (3,708 ) Total operating lease liabilities $ 75,850 Current operating lease liability $ 23,061 Long-term operating lease liability 52,789 Total operating lease liabilities $ 75,850 |
Convertible Notes and Notes Pay
Convertible Notes and Notes Payable | 3 Months Ended |
Mar. 31, 2021 | |
Debt Disclosure [Abstract] | |
Convertible Notes and Notes Payable | Note 8 – Convertible Notes and Notes Payable 2020 Convertible Notes Payable From May 15, 2020 through July 1, 2020, the Company entered into definitive securities purchase agreements (“Purchase Agreements”) with accredited investors for their purchase of (i) secured convertible notes issued by us in the aggregate original principal amount of $3,494,840 (the “Notes”), and (ii) Unit Purchase Options (“Purchase Options”) to purchase 303,623 units (each, a “Unit”), at an exercise price of $3.20 per Unit (subject to adjustments), with each Unit exercisable for (A) one share of the Company’s common stock and (B) a 5-year warrant (the “Warrants”) to purchase one share of our common stock at an exercise price of $3.20 (subject to adjustments) (the “Private Placement”). Each purchaser of a Note was issued a 5-year Purchase Option to purchase 0.086875 Units (as adjusted for subsequent reverse splits for each dollar of Notes purchased. The Company received gross proceeds of approximately $3.5 million (of which $3,351,200 was received in cash and $143,640 resulted from cancellation of indebtedness). Tribal Capital Markets, LLC acted as placement agent (the “Placement Agent”) in the Private Placement. The Company paid the Placement Agent and certain selling agents a cash fee of 8% on a portion of the proceeds for an aggregate amount of $236,000. The Company also agreed to issue the Placement Agent and the selling agent 5-year warrants to purchase 6,750 shares of our common stock at an exercise price of $3.20 per share. These warrants have the same terms and conditions as the Warrants issued in the Private Placement, except for the different exercise price. The Company received approximately $2,998,905 in net proceeds from the Private Placement, after deducting fees payable to the Placement Agent, selling agent, and investor counsel. The Company used approximately $413,456, in proceeds to repay outstanding 9% promissory notes and the Company intends to use the remaining proceeds for working capital and general corporate purposes. Pursuant to that certain Form of Secured Convertible Note entered into in connection with the Purchase Agreement, interest on such Notes accrues at a rate of ten percent (10%) per annum and is payable either in cash or in shares of the Company’s common stock at a conversion price of $3.20 (following and subject to adjustment for stock splits, combinations or similar events and anti-dilution provisions, among other adjustments) on each of the six- and twelve-month anniversary of the issuance date and on the maturity dates of November 15, 2021, December 22, 2021 and December 30, 2021. All amounts of principal and interest due under the Notes are convertible at any time after the issuance date, in whole or in part (subject to rounding for fractional shares), at the option of the holders, into the Company’s common stock at a fixed conversion price of $3.20, which is subject to adjustment as described above. Upon any issuance by the Company of any of its equity securities, including common stock, for cash consideration, indebtedness or a combination thereof after the date hereof (a “Subsequent Equity Financing”), each holder of a Note will have the option to convert the outstanding principal and accrued but unpaid interest of its Note into the number of fully paid and non-assessable shares of common stock issued in the Subsequent Equity Financing (“Conversion Securities”) equal to the product of unpaid principal, together with the balance of unpaid and accrued interest and other amounts payable hereunder multiplied by 1.1, divided by the price per share paid by the investors for the Conversion Securities. A Note may not be converted, and shares of common stock may not be issued under the Notes if, after giving effect to the conversion or issuance, the holder together with its affiliates would beneficially own in excess of 9.99% of the Company’s outstanding ordinary shares. The Company may prepay the Notes at any time in whole or in part by paying an amount equal to 100% of the principal amount to be redeemed, together with accrued and unpaid interest plus a prepayment fee equal to one percent (1%) of the principal amount to be repaid. The Notes contain customary events of default including but not limited to: (i) failure to make payments when due; and (ii) bankruptcy or insolvency of the Company. If an event of default occurs, each holder may require the Company to redeem all or any portion of the Notes (including all accrued and unpaid interest thereon), in cash. Pursuant to the terms of a Security Agreement entered into between the Company and the noteholders under the Purchase Agreements, the Notes are secured by the proceeds from the $3,000,000 milestone payment pursuant to Section 7.2(b) of the Distribution Agreement dated November 12, 2018 between the Company and Ferring to the extent such proceeds are actually received by the Company from Ferring. Of the $3,494,840 in net proceeds received in the offering, $1,048,904 million was allocated to the unit purchase options issued to investors based on their relative fair value and $2,062,586 of beneficial conversion feature based on their relative fair value. This amount represented a discount on the debt and additional paid-in-capital at the date of issuance. In November 2020, noteholders holding notes with a principal value of $1,319,840 elected to convert in connection with the public underwritten offering. In November and December 2020, the Company redeemed an additional $475,000 in principal note value. In March 2021, an additional $1,200,000 converted into equity. As of March 31, 2021, there is $500,000 in principal note value that remains outstanding. Principal balances of the 2020 Convertible Notes were as follows: March 31, 2021 December 31, 2020 2020 Convertible Notes 500,000 1,700,000 Accrued interest 13,613 24,373 Less beneficial conversion feature discount (143,777 ) (604,897 ) Less options discount (62,712 ) (224,051 ) Less warrants discount (66,374 ) (229,954 ) Less issuance cost (55,292 ) (129,408 ) Total, net of discount $ 185,458 $ 536,063 Interest expense on the 2020 Convertible Notes was $35,070 and $0 for the three months ended March 31, 2021 and 2020, respectively. Amortization of options discount on the 2020 Convertible Notes was $161,339 and $0 for the three months ended March 31, 2021 and 2020, respectively. Amortization of warrant discount on the 2020 Convertible Notes was $163,580 and $0 for the three months ended March 31, 2021 and 2020, respectively. Amortization of beneficial conversion feature on the 2020 Convertible Notes was $461,120 and $0 for the three months ended March 31, 2021 and 2020, respectively. Amortization of issuance costs on the 2020 Convertible Notes was $74,116 and $0 for the three months ended March 31, 2021 and 2020, respectively. Paycheck Protection Program On July 1, 2020, the Company received a loan in the principal amount of $157,620 pursuant to the U.S. Small Business Administration’s Paycheck Protection Program. The loan will mature 18 months from the date of funding is payable over 18 equal monthly installments, and bears interest at a rate of 1% per annum. Up to 100% of the principal balance of the loan is forgivable based upon satisfaction of certain criteria under the Paycheck Protection Program. The Company has applied for full forgiveness of the loan. |
Other Related Party Transaction
Other Related Party Transactions | 3 Months Ended |
Mar. 31, 2021 | |
Related Party Transactions [Abstract] | |
Other Related Party Transactions | Note 9 –Other Related Party Transactions In November 2020, Paulson Investment Company served as a co-managing underwriter for the Company’s underwritten public offering and received fee and commissions for such role in the amount of $271,440. Trent Davis, one of our directors is President of Paulson Investment Company. Mr. Davis did not receive any compensation related to the fees and commissions received by Paulson. |
Stockholders' Equity
Stockholders' Equity | 3 Months Ended |
Mar. 31, 2021 | |
Equity [Abstract] | |
Stockholders' Equity | Note 10 – Stockholders’ Equity Reverse Stock Splits On December 16, 2019, the Company’s stockholders approved a reverse stock split at a ratio of between 1-for 5 and 1-for-25, with discretion for the exact ratio to be approved by the Company’s board of directors. On February 19, 2020, the Company’s board of directors approved a reverse stock split of the Company’s common stock at a ratio of 1-for-20. On May 21, 2020, the Company filed a certificate of change (with an effective date of May 26, 2020) with the Nevada Secretary of State pursuant to Nevada Revised Statutes 78.209 to effectuate a 1-for-20 reverse stock split of its outstanding common stock. The reverse split took effect at the open of business on May 26, 2020. On October 22, 2020, the Company’s board of directors approved a reverse stock split of the Company’s common stock at a ratio of 5-for-8 and also approved a proportionate decrease in the Company’s authorized common stock to 125,000,000 shares from 200,000,000. On November 5, 2020, the Company filed a certificate of change (with an effective date of November 9, 2020) with the Nevada Secretary of State pursuant to Nevada Revised Statutes 78.209 to effectuate a 5-for-8 reverse stock split of its outstanding common stock. As a result of the reverse stock split, 133 shares were issued in lieu of fractional shares. On November 6, 2020, the Company received notice from FINRA/OTC Corporate Actions that the reverse split would take effect at the open of business on November 9, 2020 and the reverse stock split took effect on that date. The consolidated financial statements presented reflect the reverse splits. Public offering On November 12, 2020, the Company entered into an underwriting agreement (the “Underwriting Agreement”) with Roth Capital Partners, LLC, as representative of the several underwriters (the “Underwriters”), in connection with the Company’s public offering (the “Offering”) of 3,625,000 shares of common stock, at a public offering price of $3.20 per share. The initial closing of the Offering for 3,625,000 shares of common stock took place on November 17, 2020. On November 18, 2020, the Underwriters exercised their option pursuant to the Underwriting Agreement to purchase an additional 528,750 shares of common stock (the “Option Shares”). The closing for the Option Shares took place on November 20, 2020 for which the Company received approximately $1.5 million in net proceeds after deducting underwriting discounts and commissions. With the exercise of the option to purchase the Option Shares, the total amount of shares of common stock sold in the Offering was 4,153,750 shares with aggregate net proceeds received by the Company of approximately $11.8 million after deducting underwriting discounts and commissions and offering expenses. During the year ended December 31, 2020 the Company incurred approximately $1.8 million of offering costs related to issuance of common stock. Three months Ended March 31, 2021 In January 2021, the Company issued 30,000 shares of common stock to employees under its 2019 Stock Incentive Plan with a fair value of $97,453. During the first three month of 2021, the Company issued 71,500 shares of common stock to consultants under its 2019 Stock Incentive Plan with a fair value of $221,250. In March 2021, the Company issued 388,684 shares of common stock with fair value of $1,243,788 as a result of the conversion of notes payables and accrued interest. No gain or loss was recorded on conversion, as the issuance of common stock was pursuant to the terms of a prior agreement. In March 2021, the Company issued 77,444 shares of common stock for proceeds of $246,278 as a result of the exercise of unit purchase options. In March 2021, the Company issued 39,095 shares of common stock for proceeds of $123,562 as a result of the exercise of warrants. In March 2021, the Company issued 91,709 shares of common stock as a result of a cashless exercise of warrants. In March 2021, the Company issued 86,529 shares of common stock as a result of a cashless exercise of unit purchase options. |
Equity-Based Compensation
Equity-Based Compensation | 3 Months Ended |
Mar. 31, 2021 | |
Equity [Abstract] | |
Equity-Based Compensation | Note 11 – Equity-Based Compensation Equity Incentive Plans In October 2019, the Company adopted its 2019 Stock Incentive Plan (the “2019 Plan”). Under the 2019 Plan, the Company’s Board of Directors is authorized to grant both incentive and non-statutory stock options to purchase common stock and restricted stock awards to its employees, directors, and consultants. The 2019 Plan initially provided for the issuance of 500,000 shares. A provision in the 2019 Plan provides for an automatic annual increase equal to 6% of the total number of shares of Company common stock outstanding on December 31 of the preceding calendar year. In January 2020, the number of available shares was increased to 793,093. In January 2021, the number of available shares issuable increased by an additional 578,356 shares to a total of 1,371,449 shares. Options generally have a life of 3 to 10 years and exercise prices equal to or greater than the fair market value of the common stock as determined by the Company’s Board of Directors. Vesting for employees typically occurs over a three-year period or based on performance objectives. The following table sets forth the activity of the options to purchase common stock under the 2019 Plan. The prices represent the closing price of our common stock on the Nasdaq Capital Market on the respective dates. Options Outstanding Options Exercisable Number of Shares Price per Share Range Weighted Average Exercise Price Aggregate Intrinsic Value (1) Number of Shares Weighted Average Exercise Price Aggregate Intrinsic Value (1) Balance at December 31, 2020 594,114 $ 3.19-9.25 $ 7.28 $ - 265,386 $ 5.64 $ - Forfeited - $ - $ - - - - - Vested - - - - 97,615 3.86 - Exercised - $ - $ - - - - - Granted 508,558 $ 2.28-2.55 $ 2.33 - - - - Balance at March 31, 2021 1,102,672 $ 2.28-9.25 $ 4.33 $ - 374,256 $ 3.57 $ - (1) The intrinsic value of an option represents the amount by which the market value of the stock exceeds the exercise price of the option of in-the-money options only. The fair value of each option granted is estimated as of the grant date using the Black-Scholes option pricing model with the following assumptions: Three months ended March 31, 2021 2020 Risk-free interest rate range 0.22 to 0.31 % 0.48 to 1.65 % Expected life of option-years 5.5 to 6.5 5.20 to 5.77 Expected stock price volatility 107.4 % 110.8 to 128. % Expected dividend yield - % - % The risk-free interest rate is based on U.S. Treasury interest rates, the terms of which are consistent with the expected life of the stock options. Expected volatility is based upon the average historical volatility of the Company’s common stock over the period commensurate with the expected term of the related instrument. The expected life and estimated post-employment termination behavior is based upon historical experience of homogeneous groups, executives and non-executives, within the Company. The Company does not currently pay dividends on its common stock nor does it expect to do so in the foreseeable future. Total Intrinsic Value of Options Exercised Total Fair Value of Options Vested Year ended December 31, 2020 $ - $ 1,495,744 Three months ended March 31, 2021 $ - $ 376,523 For the three months ended March 31, 2021, the weighted average grant date fair value of options granted was $2.33 per share. The Company estimates the fair value of options at the grant date using the Black-Scholes model. For all stock options granted through March 31, 2021, the weighted average remaining service period is 4.5 years. The Company recognized $376,524 and $ 381,475 Restricted Stock and Restricted Stock Units In the three months ended March 31, 2021, the Company issued 30,000 shares of restricted stock, to certain employees. Restricted stock and restricted stock units issued to employees and directors generally vest either at grant or vest over a period of one year from grant. The following table summarizes the Company’s aggregate restricted stock awards and restricted stock unit activity during the three months ended March 31, 2021: Number of Unvested Shares Weighted Average Grant Date Fair Value Aggregate Value of Unvested Shares Balance at December 31, 2020 16,698 $ 4.67 $ 77,927 Granted 71,757 $ 3.04 $ 218,228 Vested (24,445 ) $ 3.66 $ (89,473 ) Forfeitures - $ - $ - Balance at March 31, 2021 64,010 $ 3.23 $ 206,682 The Company recognized $89,473 and $265,963 in stock-based compensation expense for restricted stock and restricted stock units for the three months ended March 31, 2021 and March 31, 2020 respectively. Stock-based compensation expense is recorded in selling, general and administrative expenses on the consolidated statement of operations |
Stock Options and Warrants
Stock Options and Warrants | 3 Months Ended |
Mar. 31, 2021 | |
Stockholders' Equity Note [Abstract] | |
Stock Options and Warrants | Note 12 – Stock Options and Warrants In connection with the issuance of the 2020 Convertible Notes, the Company also issued options to purchase 303,623 units at an exercise price of $3.20 per unit, with each unit consisting of one share of common stock, and a warrant to purchase one share of common stock at an exercise price of $3.20 per share. The units and warrants are exercisable for a period of five years from the date of issuance and are subject to a downward provision if the Company issues securities at a lower price. Warrant holders have a right to require the Company to pay cash in the event of a fundamental transaction. In accordance with ASC 815, the warrants and options issued in this period were determined to require equity treatment and $247,821 related to the options and $125,104 related to warrants was recorded in stockholders’ equity in the three months ended March 31, 2021. In connection with the issuance of the 2020 Convertible Notes, the Company agreed to issue the placement agent and the selling agent five-year warrants to purchase 6,750 shares of the Company’s common stock at an exercise price of $3.20. A Monte Carlo model was used because the investor warrants and options contain fundamental transaction payouts and reset events that cannot be modeled with a Black Scholes model. The fair value of the options and warrants issued to the convertible debt holders is estimated as of the issue date using a Monte Carlo model with the following assumptions: Risk-free interest rate range 0.33% - 0.39 % Stock Price $ 3.00 - $3.95 Expected life of warrants and option (years) 5.00 Expected stock price volatility 108.2% - 112.5 % Expected dividend yield 0 % The risk-free interest rate is based on U.S. Treasury interest rates, the terms of which are consistent with the expected life of the stock options and warrants. Expected volatility is based upon the historical volatility of the Company’s common stock over the period commensurate with the expected term of the related instrument. The options and warrants are valued assuming projected reset events adjusting the exercise price and a forced exercise upon a projected fundamental transaction by management. The options and warrants early exercise are modeled assuming registration after 180 days. The Company does not currently pay dividends on its common stock nor does it expect to in the foreseeable future. |
Income Taxes
Income Taxes | 3 Months Ended |
Mar. 31, 2021 | |
Income Tax Disclosure [Abstract] | |
Income Taxes | Note 13 – Income Taxes The Company uses the asset and liability method to account for income taxes. Under this method, deferred income tax assets and liabilities are recognized for the future tax consequences attributable to differences between the financial statement carrying amounts of existing assets and liabilities and their respective tax bases. Deferred tax assets and liabilities are measured using enacted tax rates expected to apply to taxable income in the years in which those temporary differences are expected to be recovered or settled. The effect on deferred tax assets and liabilities of a change in tax rates is recognized in income in the period that includes the enactment date. If a carryforward exists, the Company decides as to whether the carryforward will be utilized in the future. Currently, a valuation allowance is established for all deferred tax assets and carryforwards as their recoverability is deemed to be uncertain. If the Company’s expectations for future operating results at the federal or at the state jurisdiction level vary from actual results due to changes in healthcare regulations, general economic conditions, or other factors, it may need to adjust the valuation allowance, for all or a portion of the Company’s deferred tax assets. The Company’s income tax expense in future periods will be reduced or increased to the extent of offsetting decreases or increases, respectively, in the Company’s valuation allowance in the period when the change in circumstances occurs. These changes could have a significant impact on the Company’s future earnings. Income tax expense was $0 and $0 for the three months ended March 31, 2021 and 2020. The annual forecasted effective income tax rate for 2021 is 0% with a year-to-date effective income tax rate for the three months ended March 31, 2021 respectively of 0%. |
Commitments and Contingencies
Commitments and Contingencies | 3 Months Ended |
Mar. 31, 2021 | |
Commitments and Contingencies Disclosure [Abstract] | |
Commitments and Contingencies | Note 14 – Commitments and Contingencies INVO Bioscience, Inc. v. James Bowdring On August 7, 2019, the Company sent James Bowdring, the brother of the Company’s then Chief Financial Officer, a check in the amount of $65,197 as full and final payment under those certain promissory notes dated April 8, 2011 and November 9, 2011. On August 8, 2019, Mr. Bowdring’s legal counsel returned the check. The basis for returning the check was a claim that the interest due under the Notes called for compounded interest and not per annum interest, this amount is recorded in Accounts Payable and Accrued Liabilities on the Consolidated Balance Sheet. In addition, the letter rejecting the tender of the payment in full check alleged Mr. Bowdring was considering a future intention to convert his Promissory Notes into shares of the Company’s common stock. Mr. Bowdring, through his counsel, indicated that such future intention to convert the Notes to common stock were contingent upon Mr. Bowdring addressing certain personal issues which were not disclosed by his counsel in the correspondence returning the checks. The Company does not believe that Mr. Bowdring has the right to seek conversion of the Notes once payment for the Notes has been tendered. In order to resolve the issue of the Company’s tender of payment in full versus Mr. Bowdring’s assertion that he can reject tender and seek conversion, the Company has filed an action in the Suffolk Superior Court in Boston on September 3, 2019 seeking Declaratory Judgment and Judgment for Breach of Contract. On September 30, 2019, Mr. Bowdring filed an answer and counterclaim under which he alleged breach of contract, fraud, promissory estoppel, unfair and deceptive practices and constructive trust. Mr. Bowdring is seeking receipt of all shares due under the adjusted conversion price. The 10% Senior Secured Convertible Promissory Notes were issued on April 8, 2011 and November 9, 2011, with maturity dates thirty days subsequent to the dates of issuance. Interest was calculated at 10% per annum, compounded based on a 360-day year. Investors had the option to convert any unpaid principal and accrued interest into shares of Company’s common stock original conversion prices of $0.96 and $0.32, respectively, subject to adjustments upon the Company’s issuances of stock at prices less than the original conversion prices during the 24-months after issuance of each note (i.e., currently $0.2100). The Company does not currently expect the above matter to have a material adverse effect upon either the Company’s results of operations, financial position, or cash flows. |
Contracts With Customers
Contracts With Customers | 3 Months Ended |
Mar. 31, 2021 | |
Revenue from Contract with Customer [Abstract] | |
Contracts With Customers | Note 15 – Contracts with Customers The Company adopted ASC 606, Revenue from Contracts with Customers . The Company routinely enters into agreements with customers that include general commercial terms and conditions, notification requirements for price increases, shipping terms and in most cases prices for the products that it offers. However, these agreements do not obligate the Company to provide goods to the customer and there is no consideration promised to us at the onset of these arrangements. For customers without separate agreements, the Company has a standard list price established by geography and by currency for all products and our invoices contain standard terms and conditions that are applicable to those customers where a separate agreement is not controlling. The Company’s performance obligations are established when a customer submits a purchase order or notification (in writing, electronically or verbally) for goods, and it accept the order. The Company identifies performance obligations as the delivery of the requested product(s) in appropriate quantities and to the location specified in the customer’s e-mail/or purchase order. The Company generally recognizes revenue upon the satisfaction of these criteria when control of the product has been transferred to the customer at which time it has an unconditional right to receive payment. The Company’s prices are fixed and are not affected by contingent events that could impact the transaction price. The Company does not offer price concessions and does not accept payment that is less than the price stated when it accepted the purchase order, except in rare credit related circumstances. The Company does not have any material performance obligations where it is acting as an agent for another entity. Revenues for products, including: INVOcell®, INVO TM Retention System, and INVO Microscope Holding Block are typically recognized at the time the product is shipped, at which time the title passes to the customer and there are no further performance obligations. Revenues from consignment are recognized when the medical device is shipped from the consignor to the customer. In January 2019, the Company announced a U.S. license and distribution agreement with Ferring. The agreement calls for the issuance of an initial upfront payment of $5,000,000 which the Company received upon the signing of the agreement, ongoing product revenue, and then subsequent licensing fee payment of $3,000,000 that will provide the Company with a source of non-dilutive financing to execute its plan. Under the terms of the agreement the Company can pursue developing international markets and as well as partnering and opening INVO-only reproductive centers within the U.S. market. The initial upfront payment of $5,000,000 which the Company received upon the signing of the agreement is being recognized as income over the 7-year term. Under the terms of the Distribution Agreement, Ferring completed its obligation to make an initial payment to the Company of $5,000,000 upon completion of the required closing conditions, including executed agreements from all current manufacturers of the Licensed Product that upon a material supply default by the Company, Ferring can assume a direct purchase relationship with such manufacturers. Ferring is obligated to make a second payment to the Company of $3,000,000 provided that the Company is successful in obtaining a five (5) day label enhancement from the FDA for the current incubation period for the Licensed Product at least three (3) years prior to the expiration of the term of the license for the Licensed Product and provided further that Ferring has not previously exercised its right to terminate the Distribution Agreement for convenience. In addition, the Company entered into a separate Distribution Agreement. The Distribution Agreement has an initial term expiring on December 31, 2025 and at the end of the initial term it may be terminated by the Company if Ferring fails to generate specified minimum revenues to the Company from the sale of the Licensed Product during the final two years of the initial term. On March 2, 2021, the Company entered into Amendment No. 1 to the Distribution Agreement (the “Amendment”) with Ferring. Pursuant to the Amendment, Ferring agreed to purchase a 2,004 count of product for $501,000 in March 2021, at which point the minimum annual target for 2020 set forth in Section 2.4 of the Distribution Agreement was deemed to be satisfied in full as a result of such purchase. The Amendment provides for added flexibility by increasing the number of INVO company-owned clinics initially allowable under the agreement and removing certain geographical requirements. The Ferring license was deemed to be a functional license that provide customers with a “right to access” to the Company’s intellectual property during the subscription period and, accordingly, revenue is recognized over a period of time, which is generally the subscription period. During the three months ended March 31, 2021, the Company recognized $178,571 related to the Ferring license agreement. As of March 31, 2021, and March 31, 2020, the Company had deferred revenues of $3,392,857and $4,107,143, respectively. International Distribution Agreements The Company has entered into exclusive distribution agreements for a number of international markets. These agreements usually have an initial term with renewal options and require the distributors to meet minimum annual purchases, which vary depending on the market. The Company is also required to register the product in each market before the distributor can begin importing, a process and timeline that can vary widely depending on the market. INVOcell Registration Market Distribution Partner Date Initial Term Status in Country Canada Invaron Pharmaceuticals Inc. July 2020 1-Year Completed Mexico Proveedora de Equipos y Productos S.A.** Sept 2020 5-year Completed Malaysia iDS Medical Systems Nov 2020 3-year Completed Turkey Orcan Medical Oct 2019 1-year Completed Jordan Biovate Sept 2019 1-year Completed Pakistan Galaxy Pharma Dec 2020 1-year In process Thailand IVF Envimed Co., Ltd. April 2021 1-year In process Sudan Quality Medicines, Cosmetics & Medical Equipment Import Sept 2020 1-year In process Ethiopia Quality Medicines, Cosmetics & Medical Equipment Import Sept 2021 1-year In process Uganda Quality Medicines, Cosmetics & Medical Equipment Import Sept 2022 1-year In process Nigeria G-Sytems Limited Sept 2023 1-year In process Togolese Republic INVOSOLUX TOGO Nov 2019 1-year In process Iran Tasnim Behboud Dec 2020 1-year In process ** Also the JV Partner for Mexico Contract Balances The Company incurs agreement obligations on general customer purchase orders and e-mails that have been accepted but unfulfilled. Due to the short duration of time between order acceptance and delivery of the related product, the Company has determined that the balance related to these obligations is generally immaterial at any point in time. The Company monitors the value of orders accepted but unfulfilled at the close of each reporting period to determine if disclosure is appropriate. Warranty The Company’s general product warranties do not extend beyond an assurance that the product delivered will be consistent with stated specifications and do not include separate performance obligations. Significant Judgments in the Application of the Guidance in ASC 606 There are no significant judgments associated with the satisfaction of our performance obligations. The Company generally satisfies performance obligations upon delivery of the product to the customer. This is consistent with the time in which the customer obtains control of the products. Therefore, the value of unsatisfied performance obligations at the end of any reporting period is generally immaterial. The Company considers variable consideration in establishing the transaction price. Forms of variable consideration applicable to our arrangements include sales returns, rebates, volume-based bonuses, and prompt pay discounts. The Company uses historical information along with an analysis of the expected value to properly calculate and to consider the need to constrain estimates of variable consideration. Such amounts are included as a reduction to revenue from the sale of products in the periods in which the related revenue is recognized and adjusted in future periods as necessary. Commissions and Contract Costs The Company does not use or offer sales commissions of any type at this time. The Company generally does not incur incremental charges associated with securing agreements with customers which would require capitalization and recovery over the life of the agreement. Shipping and Handling Charges Fees charged to customers for shipping and handling of products are included as an offset to the costs for shipping and handling of products included as a component of cost of products. |
Subsequent Events
Subsequent Events | 3 Months Ended |
Mar. 31, 2021 | |
Subsequent Events [Abstract] | |
Subsequent Events | Note 16 – Subsequent Events On April 9, 2021, the Company entered into a partnership agreement (“Partnership Agreement”) with Lyfe Medical Center I, LLC (“Medical Center”) under which Medical Center will establish a clinic in Santa Cruz, California (the “Cruz Clinic”) to offer the INVO Procedure to its patients and where we will provide embryology laboratory services in connection with the INVO Procedure and other fertility treatments (the “Lab Services”) to patients at the Cruz Clinic. Under the terms of the Partnership Agreement, the Company will receive 40% of the net income received by the Cruz Clinic for the performance of the Lab Services under the Partnership Agreement. On April 21, 2021, the Board appointed Rebecca Messina as a director to fill the vacancy created by the expansion of the Board to seven members in November 2020. Ms. Messina will serve as a director until her successor is duly elected and qualified. After Ms. Messina’s appointment, the Board currently has seven members. In May 2021, the Company issued 24,806 shares of common stock to employees and consultants under its 2019 Stock Incentive Plan. |
Summary of Significant Accoun_2
Summary of Significant Accounting Policies (Policies) | 3 Months Ended |
Mar. 31, 2021 | |
Accounting Policies [Abstract] | |
Basis of Presentation | Basis of Presentation The accompanying consolidated balance sheets as of March 31, 2021 and December 31, 2020, the consolidated statements of operations and stockholders’ equity (deficiency) for the three months ended March 31, 2021 and 2020, and consolidated statement of cash flows for the three months ended March 31, 2021 and 2020 of the Company, and the related information contained in these notes have been prepared by management and are unaudited. In the opinion of management, all adjustments (which include normal recurring and nonrecurring items) necessary to present fairly the Company’s financial position, results of operations and cash flows in conformity with generally accepted accounting principles (“GAAP”) for the periods presented have been made. Interim operating results are not necessarily indicative of operating results for a full year. The accompanying consolidated financial statements present on a consolidated basis the accounts of the Company and its wholly owned subsidiaries. All significant intercompany accounts and transactions have been eliminated in consolidation. The preparation of the Company’s unaudited consolidated financial statements requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and the disclosure of contingent assets and liabilities at the date of the unaudited consolidated financial statements and the reported amounts of revenues and expenses during the reporting periods. Certain information and note disclosures normally included in the Company’s annual consolidated financial statements prepared in accordance with GAAP have been condensed or omitted. These unaudited consolidated financial statements should be read in conjunction with the consolidated financial statements and notes thereto included in the Company’s Annual Report on Form 10-K for the year ended December 31, 2020 previously filed by the Company with the Securities and Exchange Commission (“SEC”) on March 30, 2021. The Company considers events or transactions that have occurred after the unaudited consolidated balance sheet date of March 31, 2021, but prior to the filing of the unaudited consolidated financial statements with the SEC on this Quarterly Report on Form 10-Q, to provide additional evidence relative to certain estimates or to identify matters that require additional disclosure, as applicable. Subsequent events have been evaluated through the date of the filing of this Quarterly Report on Form 10-Q with the SEC. |
Cash and Cash Equivalents | Cash and Cash Equivalents For financial statement presentation purposes, the Company considers time deposits, certificates of deposit and all highly liquid investments with original maturities of three months or less to be cash and cash equivalents. At times, cash and cash equivalents balances exceed amounts insured by the Federal Deposit Insurance Corporation. |
Inventory | Inventory Inventories consist of raw materials, work in process and finished goods and are stated at the lower of cost or net realizable value, using the first-in, first-out (FIFO) method as a cost flow method. |
Property and Equipment | Property and Equipment The Company records property and equipment at cost. Property and equipment is depreciated using the straight-line method over the estimated economic lives of the assets, which are from 3 to 10 years. The Company capitalizes the expenditures for major renewals and improvements that extend the useful lives of property and equipment. Expenditures for maintenance and repairs are charged to expense as incurred. The Company reviews the carrying value of long-lived assets for impairment at least annually or whenever events or changes in circumstances indicate that the carrying amount of an asset may not be recoverable. Recoverability of long-lived assets is measured by a comparison of its carrying amount to the undiscounted cash flows that the asset or asset group is expected to generate. If such assets are considered impaired, the impairment to be recognized is measured by the amount by which the carrying amount of the property, if any, exceeds its fair market value. |
Stock Based Compensation | Stock Based Compensation The Company accounts for stock-based compensation under the provisions of Accounting Standards Codification (“ASC”) subtopic 718-10, Compensation (“ASC 718-10”). This statement requires the Company to measure the cost of employee services received in exchange for an award of equity instruments based on the grant-date fair value of the award. That cost is recognized over the period in which the employee is required to provide service or based on performance goals in exchange for the award, which is usually the vesting period. |
Loss Per Share | Loss Per Share Basic loss per share calculations are computed by dividing income (loss) available to common shareholders by the weighted-average number of common shares outstanding. Diluted earnings per share are computed similar to basic earnings per share except that the denominator is increased to include potentially dilutive securities. The Company’s diluted loss per share is the same as the basic loss per share for the three months ended March 31, 2021 and 2020, as the inclusion of any potential shares would have had an anti-dilutive effect due to the Company generating a loss. Three Months Ended March 31, 2021 2020 Loss to common shareholders (Numerator) $ (2,453,469 ) $ (1,444,392 ) Basic and diluted weighted-average number of common shares outstanding (Denominator) 9,888,025 4,917,997 The Company has excluded the following dilutive securities from the calculation of fully diluted shares outstanding because the result would have been anti-dilutive: Three Months Ended March 31, 2021 2020 Effect of dilutive common stock equivalents: Options 1,102,672 - Convertible notes and interest 160,504 - Unit purchase options and warrants 216,193 - Total 1,479,369 - |
Business Segments | Business Segments The Company operates in one segment and therefore segment information is not presented. |
Revenue Recognition | Revenue Recognition The Company recognizes revenue on arrangements in accordance with ASC 606, Revenue from Contracts with Customers (“ASC 606”). The core principle of ASC 606 is to recognize revenues when promised goods or services are transferred to customers in an amount that reflects the consideration to which an entity expects to be entitled for those goods or services ASC 606 requires companies to assess their contracts to determine the timing and amount of revenue to recognize under the new revenue standard. The model has a five-step approach: 1. Identify the contract with the customer. 2. Identify the performance obligations in the contract. 3. Determine the total transaction price. 4. Allocate the total transaction price to each performance obligation in the contract. 5. Recognize as revenue when (or as) each performance obligation is satisfied. Revenues for products, including: INVOcell®, INVO TM Retention System, and INVO Microscope Holding Block are typically recognized at the time the product is shipped, at which time the title passes to the customer, and there are no further performance obligations. On November 12, 2018, the Company entered into a U.S. Distribution Agreement (the “Distribution Agreement”) with Ferring International Center S.A. (“Ferring”), pursuant to which it granted Ferring an exclusive license in the United States market only, with rights to sublicense under patents related to our proprietary intravaginal culture device (INVOcell™), together with the retention device and any other applicable accessories (collectively, the “Licensed Product”) to market, promote, distribute and sell the Licensed Product with respect to all therapeutic, prophylactic and diagnostic uses of medical devices or pharmaceutical products involving reproductive technology (including infertility treatment) in humans. The Ferring license was deemed to be a functional license that provide customers with a “right to access” to the Company’s intellectual property during the subscription period and accordingly, under ASC 606-10-55-60 revenue is recognized over a period of time, which is generally the subscription period. The initial upfront payment of $5,000,000 which was received upon the signing of the agreement is being recognized as income over the 7-year term. |
Long- Lived Assets | Long- Lived Assets Long-lived assets and certain identifiable assets related to those assets are periodically reviewed for impairment whenever circumstances and situations change such that there is an indication that the carrying amounts may not be recoverable. If the non-discounted future cash flows of the asset are less than their carrying amount, their carrying amounts are reduced to the fair value and an impairment loss recognized. There was no impairment recorded during the three months ended March 31, 2021 and 2020. |
Investment in Joint Ventures | Investment in Joint Ventures The following table sets forth a list of the Company’s current joint venture arrangements: Subsidiary Name Country Percent (%) Ownership HRCFG INVO, LLC United States 50% Positib Fertility, S.A. de C.V. Mexico 33% SNS MURNI INVO Bioscience Malaysia Sendirian Berhad Malaysia 50% Ginekalix INVO Bioscience LLC Skopje North Macedonia 50% Medesole INVO Bioscience India India 50% Alabama JV Agreement On March 10, 2021, the Company’s wholly owned subsidiary, INVO Centers, LLC (“INVO Centers”), entered into a limited liability company agreement (the “JV LLC Agreement”) with HRCFG, LLC (“HRCFG”) to form a joint venture for the purpose of commercializing INVOcell and the INVO Procedure at a dedicated fertility clinic in Birmingham, Alabama. The name of the joint venture LLC is HRCFG INVO, LLC (the “Alabama JV”). The responsibilities of HRCFG’s principals include providing clinical practice expertise, performing recruitment functions, providing all necessary training, and providing day-to-day management of the clinic. The responsibilities of INVO Centers will be to provide access to and be the exclusive provider to the Alabama JV of the INVOcell and the INVO Procedure. INVO Centers will also perform all required in vitro fertilization, industry specific compliance and accreditation functions, and product documentation for product registration. The Company will also provide certain funding to the Alabama JV. In connection with the formation of the Alabama JV, the Company provided an initial $30,000 in funding, in exchange for a note issued by HRCFG, which will be repaid from the operating profit of the Alabama JV. On March 19, 2021, the Company provided an additional $250,000 to HRCFG pursuant the note. Interest on the note accrues at a rate of 1.5% per annum. In addition, the Company has agreed to issue 25,000 shares of its common stock to HRCFG (i) upon opening the Birmingham clinic for business, and (ii) upon each additional INVOcell clinic opened for business by the Alabama JV. As of March 31, 2021, the Company had expended $64,932 in startup costs related to this joint venture. Mexico JV Agreement Effective September 24, 2020, INVO Centers, LLC entered into a Pre-Incorporation and Shareholders Agreement with Francisco Arredondo, MD PLLC (“Arredondo”) and Security Health LLC, a Texas limited liability company (“Ramirez”, and together with INVO and Arredondo, the “Shareholders”) under which the Shareholders will commercialize the INVO Procedure and offer related medical treatments in Mexico. Each party owns one-third of the Mexican incorporated company, Positib Fertility, S.A. de C.V. (the “Mexico JV”). The Mexico JV will acquire the INVOcell product at cost plus any incurred shipping, customs and related fees. The Mexico JV will operate in Monterrey Nuevo Leon, Mexico and any other cities and places in Mexico as approved by the Mexico JV’s board of directors and Shareholders. In addition, the Shareholders agreed that the Mexico JV will be the Company’s exclusive distributor in Mexico. The Shareholders also agreed not to compete directly or indirectly with the Mexico JV in Mexico. As of March 31, 2021, the Company had expended $51,670 in startup costs related to this joint venture. Malaysia JV Agreement On November 23, 2020, the Company entered into a joint venture agreement with SNS Murni SDN BHD (“SNS Murni”), a company incorporated in Malaysia, to establish an exclusive joint venture in Malaysia to (i) introduce, promote and market its technologies related to the INVOcell and INVO Procedure in dedicated government-owned fertility clinics in Malaysia, and (ii) establish INVO Clinics in Malaysia. The joint venture is co-managed and owned 50% by each of INVO Bioscience and SNS Murni. As of March 31, 2021, the Company has expended $7,885 in startup costs related to this joint venture. North Macedonia JV Agreement On November 23, 2020, the Company entered into a joint venture agreement with Ginekaliks Dooel (“Ginekaliks”), a limited liability company incorporated in the Republic of North Macedonia, to establish an exclusive joint venture to (i) commercialize, introduce, promote and market technologies related to the INVOcell and INVO Procedure in North Macedonia, (ii) establish a private healthcare institution to offer the INVO Procedure. The joint venture will be co-managed and owned 50% by each of INVO Bioscience and Ginekaliks. As of March 31, 2021, the Company had expended $2,597 in startup costs related to this joint venture. India JV Agreement On January 13, 2020, the Company entered into a joint venture agreement (the “Agreement”) with Medesole Healthcare and Trading Private Limited, India (“Medesole”), an Indian corporation that promotes and distributes healthcare technologies, medical equipment and allied services to hospitals, clinics and primary health care centers in India and the Middle East. Pursuant to the Agreement, the Company and Medesole have formed a joint venture entity incorporated and registered in India, which will operate under the name Medesole INVO Bioscience India Private Limited (the “India JV”). After formation, the Company will grant to the India JV all required licenses for promoting, marketing and selling the Company’s INVOcell® technology in India. The Company and Medesole intend that the India JV will open and operate dedicated INVOcell® clinics only in India. The India JV will be co-managed and owned 50% by each of INVO and Medesole, who will share equally in the expenditures, revenues and profits of the India JV. The Agreement has a term of three years and may be terminated by either party on 180 days’ prior written notice. |
Variable Interest Entities | Variable Interest Entities The Company’s consolidated financial statements include the accounts of the Company, its wholly owned subsidiaries and variable interest entities (“VIE’), where the Company is the primary beneficiary under the provisions of the ASC 810, Consolidation (“ASC 810”). Management makes judgments regarding the Company’s level of influence or control over an entity and whether or not the Company is the primary beneficiary of a VIE. Various factors are considered in this analysis, including but not limited to the Company’s ability to direct the activities that most significantly impact the entity’s governing body, the size and seniority of the Company’s investment, the Company’s ability and the rights of other investors to participate in policy making decisions, the Company’s ability to replace the manager and/or liquidate the entity, and the Company’s obligation to absorb losses and right to receive benefits that are significant. Management’s ability to correctly assess its influence or control over an entity when determining the primary beneficiary of a VIE affects the presentation of these entities in the Company’s consolidated financial statements. If it is determined that the Company is the primary beneficiary of a VIE, the Company’s financial statements would consolidate the VIE. The Company performs a qualitative assessment of its joint ventures on an ongoing basis to determine if it continues to be a primary beneficiary. The Company concluded it has a variable interest in the Alabama JV and the Mexico JV (the “JVs”) on the basis of its capital contributions to the JVs and the terms and conditions contained in the agreements that control the JVs. First, the Company determined that the JVs are VIEs, since the JVs’ equity at risk, as defined by GAAP, is considered to be insufficient to finance JV activities without additional support. Second, the Company determined that it has a controlling financial interest in, and thus is a primary beneficiary of the JVs. Such control stems from the Company’s power to direct activities that most significantly impact the JVs operations, and the Company’s obligation to absorb losses and its right to receive benefits from the JVs that would be significant to the JVs. Such power stems from the Company’s ability, among other things, to control the sale or transfer of the JVs capital units and/or common stock. As a result of its analysis, the Company concluded that it is a primary beneficiary of the JVs and therefore consolidates the balance sheets, results of operations and cash flows of the JVs into its own. As of March 31, 2021, there was no financial activity in the JV’s and therefore no impact on the Company’s financial statements. |
Recently Adopted Accounting Pronouncements | Recently Adopted Accounting Pronouncements None. |
Summary of Significant Accoun_3
Summary of Significant Accounting Policies (Tables) | 3 Months Ended |
Mar. 31, 2021 | |
Accounting Policies [Abstract] | |
Schedule of Earning Per Share Basic and Diluted | The Company’s diluted loss per share is the same as the basic loss per share for the three months ended March 31, 2021 and 2020, as the inclusion of any potential shares would have had an anti-dilutive effect due to the Company generating a loss. Three Months Ended March 31, 2021 2020 Loss to common shareholders (Numerator) $ (2,453,469 ) $ (1,444,392 ) Basic and diluted weighted-average number of common shares outstanding (Denominator) 9,888,025 4,917,997 |
Schedule of Antidilutive Securities Excluded from Computation of Earnings Per Share | The Company has excluded the following dilutive securities from the calculation of fully diluted shares outstanding because the result would have been anti-dilutive: Three Months Ended March 31, 2021 2020 Effect of dilutive common stock equivalents: Options 1,102,672 - Convertible notes and interest 160,504 - Unit purchase options and warrants 216,193 - Total 1,479,369 - |
Schedule of Investment in Joint Ventures | The following table sets forth a list of the Company’s current joint venture arrangements: Subsidiary Name Country Percent (%) Ownership HRCFG INVO, LLC United States 50% Positib Fertility, S.A. de C.V. Mexico 33% SNS MURNI INVO Bioscience Malaysia Sendirian Berhad Malaysia 50% Ginekalix INVO Bioscience LLC Skopje North Macedonia 50% Medesole INVO Bioscience India India 50% |
Inventory (Tables)
Inventory (Tables) | 3 Months Ended |
Mar. 31, 2021 | |
Inventory Disclosure [Abstract] | |
Schedule of Inventory | Components of inventory are: March 31, 2021 December 31, 2020 Raw materials $ 67,936 $ 72,022 Work in process 5,005 29,645 Finished goods 195,408 163,705 Total inventory $ 268,349 $ 265,372 |
Property and Equipment (Tables)
Property and Equipment (Tables) | 3 Months Ended |
Mar. 31, 2021 | |
Property, Plant and Equipment [Abstract] | |
Schedule of Esimated Useful Lives of Property and Equipment | The estimated useful lives and accumulated depreciation for furniture, equipment and software are as follows as of March 31, 2021 and December 31, 2020: Estimated Useful Life Manufacturing equipment 6 to 10 years Medical equipment 10 years Office equipment 3 to 7 years |
Schedule of Property and Equipment | March 31, 2021 December 31, 2020 Manufacturing equipment $ 132,513 $ 132,513 Medical equipment 49,261 49,261 Office equipment 2,689 2,689 Less: accumulated depreciation (54,784 ) (52,257 ) Total equipment, net $ 129,679 $ 132,206 |
Patents and Trademarks (Tables)
Patents and Trademarks (Tables) | 3 Months Ended |
Mar. 31, 2021 | |
Goodwill and Intangible Assets Disclosure [Abstract] | |
Schedule of Finite-Lived Intangible Assets | The Company has recorded the following patent costs: March 31, 2021 December 31, 2020 Patents $ 95,353 $ 77,722 Accumulated amortization (72,747 ) (72,295 ) Total patent costs, net $ 22,606 $ 5,427 |
Notes Receivable (Tables)
Notes Receivable (Tables) | 3 Months Ended |
Mar. 31, 2021 | |
Debt Disclosure [Abstract] | |
Schedule of Notes Receivable | The following table lists the Company’s notes receivable: March 31, 2021 December 31, 2020 Notes receivable – HRCFG, LLC $ 280,160 $ - Total notes receivable $ 280,160 $ - |
Leases (Tables)
Leases (Tables) | 3 Months Ended |
Mar. 31, 2021 | |
Disclosure Text Block [Abstract] | |
Schedule of Lease Components | As of March 31, 2021, the Company’s lease components included in the consolidated balance sheet were as follows: Lease component Balance sheet classification March 31, 2021 Assets ROU assets - operating lease Other assets $ 73,644 Total ROU assets $ 73,644 Liabilities Current operating lease liability Current liabilities $ 23,061 Long-term operating lease liability Other liabilities 52,789 Total lease liabilities $ 75,850 |
Schedule of Future Minimum Lease Payaments | Future minimum lease payments under non-cancellable leases were as follows: March 31, 2021 2021 $ 18,751 2022 25,585 2023 26,352 2024 8,870 2025 and beyond - Total future minimum lease payments $ 79,558 Less: Interest (3,708 ) Total operating lease liabilities $ 75,850 Current operating lease liability $ 23,061 Long-term operating lease liability 52,789 Total operating lease liabilities $ 75,850 |
Convertible Notes And Notes P_2
Convertible Notes And Notes Payable (Tables) | 3 Months Ended |
Mar. 31, 2021 | |
Debt Disclosure [Abstract] | |
Schedule of Convertible Notes | Principal balances of the 2020 Convertible Notes were as follows: March 31, 2021 December 31, 2020 2020 Convertible Notes 500,000 1,700,000 Accrued interest 13,613 24,373 Less beneficial conversion feature discount (143,777 ) (604,897 ) Less options discount (62,712 ) (224,051 ) Less warrants discount (66,374 ) (229,954 ) Less issuance cost (55,292 ) (129,408 ) Total, net of discount $ 185,458 $ 536,063 |
Equity-Based Compensation (Tabl
Equity-Based Compensation (Tables) | 3 Months Ended |
Mar. 31, 2021 | |
Equity [Abstract] | |
Schedule of Stock Options Activity | The following table sets forth the activity of the options to purchase common stock under the 2019 Plan. The prices represent the closing price of our common stock on the Nasdaq Capital Market on the respective dates. Options Outstanding Options Exercisable Number of Shares Price per Share Range Weighted Average Exercise Price Aggregate Intrinsic Value (1) Number of Shares Weighted Average Exercise Price Aggregate Intrinsic Value (1) Balance at December 31, 2020 594,114 $ 3.19-9.25 $ 7.28 $ - 265,386 $ 5.64 $ - Forfeited - $ - $ - - - - - Vested - - - - 97,615 3.86 - Exercised - $ - $ - - - - - Granted 508,558 $ 2.28-2.55 $ 2.33 - - - - Balance at March 31, 2021 1,102,672 $ 2.28-9.25 $ 4.33 $ - 374,256 $ 3.57 $ - (1) The intrinsic value of an option represents the amount by which the market value of the stock exceeds the exercise price of the option of in-the-money options only. |
Schedule of Share-based Payment Award, Stock Options, Valuation Assumptions | The fair value of each option granted is estimated as of the grant date using the Black-Scholes option pricing model with the following assumptions: Three months ended March 31, 2021 2020 Risk-free interest rate range 0.22 to 0.31 % 0.48 to 1.65 % Expected life of option-years 5.5 to 6.5 5.20 to 5.77 Expected stock price volatility 107.4 % 110.8 to 128. % Expected dividend yield - % - % |
Schedule of Share Based Payments Arrangements Options Exercised and Options Vested | Total Intrinsic Value of Options Exercised Total Fair Value of Options Vested Year ended December 31, 2020 $ - $ 1,495,744 Three months ended March 31, 2021 $ - $ 376,523 |
Schedule of Aggregate Restricted Stock Awards and Restricted Stock Unit Activity | The following table summarizes the Company’s aggregate restricted stock awards and restricted stock unit activity during the three months ended March 31, 2021: Number of Unvested Shares Weighted Average Grant Date Fair Value Aggregate Value of Unvested Shares Balance at December 31, 2020 16,698 $ 4.67 $ 77,927 Granted 71,757 $ 3.04 $ 218,228 Vested (24,445 ) $ 3.66 $ (89,473 ) Forfeitures - $ - $ - Balance at March 31, 2021 64,010 $ 3.23 $ 206,682 |
Stock Options and Warrants (Tab
Stock Options and Warrants (Tables) | 3 Months Ended |
Mar. 31, 2021 | |
Equity [Abstract] | |
Schedule of Fair Value Measurement Inputs and Valuation Techniques | The fair value of the options and warrants issued to the convertible debt holders is estimated as of the issue date using a Monte Carlo model with the following assumptions: Risk-free interest rate range 0.33% - 0.39 % Stock Price $ 3.00 - $3.95 Expected life of warrants and option (years) 5.00 Expected stock price volatility 108.2% - 112.5 % Expected dividend yield 0 % |
Contracts With Customers (Table
Contracts With Customers (Tables) | 3 Months Ended |
Mar. 31, 2021 | |
Revenue from Contract with Customer [Abstract] | |
Schedule of International Distribution Agreements | The Company is also required to register the product in each market before the distributor can begin importing, a process and timeline that can vary widely depending on the market. INVOcell Registration Market Distribution Partner Date Initial Term Status in Country Canada Invaron Pharmaceuticals Inc. July 2020 1-Year Completed Mexico Proveedora de Equipos y Productos S.A.** Sept 2020 5-year Completed Malaysia iDS Medical Systems Nov 2020 3-year Completed Turkey Orcan Medical Oct 2019 1-year Completed Jordan Biovate Sept 2019 1-year Completed Pakistan Galaxy Pharma Dec 2020 1-year In process Thailand IVF Envimed Co., Ltd. April 2021 1-year In process Sudan Quality Medicines, Cosmetics & Medical Equipment Import Sept 2020 1-year In process Ethiopia Quality Medicines, Cosmetics & Medical Equipment Import Sept 2021 1-year In process Uganda Quality Medicines, Cosmetics & Medical Equipment Import Sept 2022 1-year In process Nigeria G-Sytems Limited Sept 2023 1-year In process Togolese Republic INVOSOLUX TOGO Nov 2019 1-year In process Iran Tasnim Behboud Dec 2020 1-year In process ** Also the JV Partner for Mexico |
Summary of Significant Accoun_4
Summary of Significant Accounting Policies (Details Narrative) - USD ($) | Mar. 31, 2021 | Mar. 10, 2021 | Nov. 09, 2020 | Nov. 05, 2020 | May 26, 2020 | May 21, 2020 | Mar. 31, 2021 | Nov. 23, 2020 | Jan. 13, 2020 |
Proceeds from License Fees Received | $ 5,000,000 | ||||||||
Stockholders' Equity, Reverse Stock Split | 5-for-8 | 78.209 to effectuate a 5-for-8 reverse stock split | 1-for-20 | 78.209 to effectuate a 1-for-20 reverse stock split | |||||
HRCFG INVO, LLC [Member] | |||||||||
Debt interest | $ 250,000 | ||||||||
Number of shares issued for common stock | 25,000 | ||||||||
JV LLC Agreement [Member] | HRCFG INVO, LLC [Member] | |||||||||
Initial funding | $ 30,000 | ||||||||
Intrest rate | 1.50% | ||||||||
Startup costs | $ 64,932 | ||||||||
Mexico JV Agreement [Member] | Francisco Arredondo, MD PLLC and Security Health LLC [Member] | |||||||||
Startup costs | 51,670 | ||||||||
Malaysia JV Agreement [Member] | SNS Murni [Member] | |||||||||
Startup costs | 7,885 | ||||||||
Joint venture owned percentage | 50.00% | ||||||||
North Macedonia JV Agreement [Member] | Ginekaliks [Member] | |||||||||
Startup costs | $ 2,597 | ||||||||
Joint venture owned percentage | 50.00% | ||||||||
Medesole JV Agreement [Member] | Medesole Healthcare and Trading Private Limited [Member] | |||||||||
Joint venture owned percentage | 50.00% | ||||||||
Minimum [Member] | |||||||||
Property, Plant and Equipment, Estimated Useful Lives | P3Y | ||||||||
Maximum [Member] | |||||||||
Property, Plant and Equipment, Estimated Useful Lives | P10Y |
Summary of Significant Accoun_5
Summary of Significant Accounting Policies - Schedule of Earning Per Share Basic and Diluted (Details) - USD ($) | 3 Months Ended | |
Mar. 31, 2021 | Mar. 31, 2020 | |
Schedule of Earnings Per Share, Basic and Diluted [Abstract] | ||
Loss to common shareholders (Numerator) | $ (2,453,469) | $ (1,444,392) |
Basic and diluted weighted-average number of common shares outstanding (Denominator) | 9,888,025 | 4,917,997 |
Summary of Significant - Schedu
Summary of Significant - Schedule of Antidilutive Securities Excluded from Computation of Earnings Per Share (Details) - shares | 3 Months Ended | |
Mar. 31, 2021 | Mar. 31, 2020 | |
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share, Amount | 1,479,369 | |
Option [Member] | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share, Amount | 1,102,672 | |
Convertible Note and Interest [Member] | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share, Amount | 160,504 | |
Unit Purchase option and Warrants [Member] | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share, Amount | 216,193 |
Summary of Significant Accoun_6
Summary of Significant Accounting Policies - Schedule of Investment in Joint Ventures (Details) | Mar. 31, 2021 |
HRCFG INVO, LLC [Member] | United States [Member] | |
Percent (%) Ownership | 50.00% |
Positib Fertility, S.A. de C.V [Member] | Mexico [Member] | |
Percent (%) Ownership | 33.00% |
SNS MURNI INVO Bioscience Malaysia Sendirian Berhad [Member] | Malaysia [Member] | |
Percent (%) Ownership | 50.00% |
Ginekalix INVO Bioscience LLC Skopje [Member] | North Macedonia [Member] | |
Percent (%) Ownership | 50.00% |
Medesole INVO Bioscience India [Member] | India [Member] | |
Percent (%) Ownership | 50.00% |
Inventory - Schedule of Invento
Inventory - Schedule of Inventory, Current (Details) - USD ($) | Mar. 31, 2021 | Dec. 31, 2020 |
Schedule of Inventory, Current [Abstract] | ||
Raw Materials | $ 67,936 | $ 72,022 |
Work in Process | 5,005 | 29,645 |
Finished Goods | 195,408 | 163,705 |
Total Inventory | $ 268,349 | $ 265,372 |
Property and Equipment (Details
Property and Equipment (Details Narrative) - USD ($) | 3 Months Ended | |
Mar. 31, 2021 | Mar. 31, 2020 | |
Property, Plant and Equipment [Abstract] | ||
Depreciation | $ 2,431 | $ 2,431 |
Property and Equipment - Proper
Property and Equipment - Property, Plant and Equipment, Estimated Useful Life (Details) | 3 Months Ended | 12 Months Ended |
Mar. 31, 2021 | Dec. 31, 2020 | |
Medical equipment [Member] | ||
Property, Plant and Equipment [Line Items] | ||
Estimated Useful Life | 10 years | 10 years |
Minimum [Member] | Manufacturing equipment [Member] | ||
Property, Plant and Equipment [Line Items] | ||
Estimated Useful Life | 6 years | 6 years |
Minimum [Member] | Office Equipment [Member] | ||
Property, Plant and Equipment [Line Items] | ||
Estimated Useful Life | 3 years | 3 years |
Maximum [Member] | Manufacturing equipment [Member] | ||
Property, Plant and Equipment [Line Items] | ||
Estimated Useful Life | 10 years | 10 years |
Maximum [Member] | Office Equipment [Member] | ||
Property, Plant and Equipment [Line Items] | ||
Estimated Useful Life | 7 years | 7 years |
Property and Equipment - Prop_2
Property and Equipment - Property, Plant and Equipment (Details) - USD ($) | Mar. 31, 2021 | Dec. 31, 2020 |
Property, Plant and Equipment [Line Items] | ||
Accumulated depreciation | $ (54,784) | $ (52,257) |
Property and equipment, net | 129,679 | 132,206 |
Manufacturing equipment [Member] | ||
Property, Plant and Equipment [Line Items] | ||
Property, plant and Equipment, gross | 132,513 | 132,513 |
Medical equipment [Member] | ||
Property, Plant and Equipment [Line Items] | ||
Property, plant and Equipment, gross | 49,261 | 49,261 |
Office Equipment [Member] | ||
Property, Plant and Equipment [Line Items] | ||
Property, plant and Equipment, gross | $ 2,689 | $ 2,689 |
Patents and Trademarks (Details
Patents and Trademarks (Details Narrative) - USD ($) | 3 Months Ended | |
Mar. 31, 2021 | Mar. 31, 2020 | |
Goodwill and Intangible Assets Disclosure [Abstract] | ||
Amortization of Intangible Assets | $ 452 | $ 452 |
Trademark assets | $ 11,349 |
Patents and Trademarks - Schedu
Patents and Trademarks - Schedule of Finite-Lived Intangible Assets (Details) - USD ($) | Mar. 31, 2021 | Dec. 31, 2020 |
Schedule of Finite-Lived Intangible Assets [Abstract] | ||
Patents | $ 95,353 | $ 77,722 |
Accumulated Amortization | (72,747) | (72,295) |
Total patent costs, net | $ 22,606 | $ 5,427 |
Notes Receivable (Details Narra
Notes Receivable (Details Narrative) - HRCFG, LLC [Member] | Mar. 10, 2021 | Mar. 31, 2021USD ($) |
Accrues interest per annual term | 0.015 | |
Repayment of principal and interest paid | 0.030 | |
Notes receivable | $ 280,000 | |
Interest receivable | $ 160 |
Notes Receivable - Schedule of
Notes Receivable - Schedule of Notes Receivable (Details) - USD ($) | Mar. 31, 2021 | Dec. 31, 2020 |
Total notes receivable | $ 280,160 | |
HRCFG, LLC [Member] | ||
Total notes receivable | $ 280,160 |
Leases (Details Narrative)
Leases (Details Narrative) | 12 Months Ended |
Dec. 31, 2020 | |
Disclosure Text Block [Abstract] | |
Lessee, Operating Lease, Term of Contract | 5 years |
Lessee, Operating Lease, Renewal Term | 3 years |
Applicable Federal Rate | 0.30 |
Leases - Lessee, Operating Leas
Leases - Lessee, Operating Lease, Disclosure (Details) - USD ($) | Mar. 31, 2021 | Dec. 31, 2020 |
Lessee, Operating Lease, Disclosure [Abstract] | ||
ROU assets - operating lease | $ 73,644 | $ 79,319 |
Total ROU assets | 73,644 | |
Current operating lease liability | 23,061 | 22,707 |
Long-term operating lease liability | 52,789 | $ 58,634 |
Total lease liabilities | $ 75,850 |
Leases - Lessee, Operating Le_2
Leases - Lessee, Operating Lease, Liability, Maturity (Details) - USD ($) | Mar. 31, 2021 | Dec. 31, 2020 |
Lessee, Operating Lease, Liability, Maturity [Abstract] | ||
2021 | $ 18,751 | |
2022 | 25,585 | |
2023 | 26,352 | |
2024 | 8,870 | |
2025 and beyond | ||
Total future minimum lease payments | 79,558 | |
Less: Interest | (3,708) | |
Total operating lease liabilities | 75,850 | |
Current operating lease liability | 23,061 | $ 22,707 |
Long-term operating lease liability | $ 52,789 | $ 58,634 |
Convertible Notes and Notes P_3
Convertible Notes and Notes Payable (Details Narrative) - USD ($) | Jul. 01, 2020 | Nov. 12, 2018 | Mar. 31, 2021 | Jul. 01, 2020 | Mar. 31, 2021 | Mar. 31, 2020 | Dec. 31, 2020 | Nov. 30, 2020 |
Amortization of options discount | $ 860,155 | $ 39,918 | ||||||
Paycheck Protection Program [Member] | ||||||||
Debt Instrument, Face Amount | $ 157,620 | $ 157,620 | ||||||
Interest rate | 1.00% | 1.00% | ||||||
Debt maturity date, description | The loan will mature 18 months from the date of funding is payable over 18 equal monthly installments | |||||||
Debt instrument description | The loan is forgivable up to 100% of the principal balance based upon satisfaction of certain criteria under the Paycheck Protection Program. | |||||||
2020 Convertible Notes Payable [Member] | ||||||||
Interest expense | 35,070 | 0 | ||||||
Amortization of options discount | 161,339 | 0 | ||||||
Amortization of warrant discount | 163,580 | 0 | ||||||
Amortization of beneficial conversion feature | 461,120 | 0 | ||||||
Amortization of issuance costs | 74,116 | $ 0 | ||||||
2020 Convertible Notes Payable [Member] | Public Underwritten Offering [Member] | ||||||||
Debt Instrument, Face Amount | $ 1,319,840 | |||||||
Unit options to purchase | 1,048,904 | 1,048,904 | ||||||
Proceeds from offering | $ 3,494,840 | |||||||
Fair value of beneficial conversion feature | 2,062,586 | |||||||
2020 Convertible Notes Payable [Member] | Tribal Capital Markets, LLC [Member] | ||||||||
Proceeds from private placement | 2,998,905 | |||||||
Proceeds to repay convertible debt | $ 413,456 | |||||||
Outstanding notes percentage | 9.00% | |||||||
2020 Convertible Notes Payable [Member] | Purchase Agreements [Member] | ||||||||
Debt Instrument, Face Amount | $ 3,494,840 | $ 500,000 | $ 3,494,840 | $ 500,000 | $ 475,000 | $ 475,000 | ||
Proceeds from convertible debt | $ 3,500,000 | |||||||
Debt instrument converted amount | $ 1,200,000 | |||||||
2020 Convertible Notes Payable [Member] | Purchase Agreements [Member] | Tribal Capital Markets, LLC [Member] | ||||||||
Cash fee percentage | 8.00% | |||||||
Proceeds from private placement | $ 236,000 | |||||||
2020 Convertible Notes Payable [Member] | Purchase Agreements [Member] | Received in Cash [Member] | ||||||||
Proceeds from convertible debt | 3,351,200 | |||||||
2020 Convertible Notes Payable [Member] | Purchase Agreements [Member] | Cancellation of Indebtedness [Member] | ||||||||
Proceeds from convertible debt | $ 143,640 | |||||||
2020 Convertible Notes Payable [Member] | Purchase Agreements [Member] | Purchaser [Member] | ||||||||
Unit options description | Each purchaser of a Note was issued a 5-year Purchase Option to purchase 0.086875 Units (as adjusted for the Reverse Splits (as defined below) for each dollar of Notes purchased. | |||||||
2020 Convertible Notes Payable [Member] | Purchase Agreements [Member] | Warrant [Member] | ||||||||
Warrants term | 5 years | 5 years | ||||||
Warrants to pruchase | 1 | 1 | ||||||
Warrants exercise price | $ 3.20 | $ 3.20 | ||||||
2020 Convertible Notes Payable [Member] | Purchase Agreements [Member] | Warrant [Member] | Tribal Capital Markets, LLC [Member] | ||||||||
Warrants term | 5 years | 5 years | ||||||
Warrants to pruchase | 6,750 | 6,750 | ||||||
Warrants exercise price | $ 3.20 | $ 3.20 | ||||||
2020 Convertible Notes Payable [Member] | Purchase Agreements [Member] | Purchase Options [Member] | ||||||||
Unit options to purchase | 303,623 | 303,623 | ||||||
Exercise price | $ 3.20 | $ 3.20 | ||||||
2020 Convertible Notes Payable [Member] | Distribution Agreement [Member] | ||||||||
Proceeds from milestone payment | $ 3,000,000 | |||||||
Secured Convertible Note [Member] | Purchase Agreements [Member] | ||||||||
Interest rate | 10.00% | 10.00% | ||||||
Debt conversion price | $ 3.20 | $ 3.20 | ||||||
Debt maturity date, description | The maturity dates of November 15, 2021, December 22, 2021 and December 30, 2021. | |||||||
Debt instrument, convertible, terms of conversion feature | A Note may not be converted, and shares of common stock may not be issued under the Notes if, after giving effect to the conversion or issuance, the holder together with its affiliates would beneficially own in excess of 9.99% of our outstanding ordinary shares. | |||||||
Debt instrument, payment terms | The Company may prepay the Notes at any time in whole or in part by paying an amount equal to 100% of the principal amount to be redeemed, together with accrued and unpaid interest plus a prepayment fee equal to one percent (1%) of the principal amount to be repaid. |
Convertible Notes and Notes P_4
Convertible Notes and Notes Payable - Schedule of Convertible Notes (Details) - USD ($) | Mar. 31, 2021 | Dec. 31, 2020 |
Debt Disclosure [Abstract] | ||
2020 Convertible Notes | $ 500,000 | $ 1,700,000 |
Accrued interest | 13,613 | 24,373 |
Less beneficial conversion feature discount | (143,777) | (604,897) |
Less options discount | (62,712) | (224,051) |
Less warrants discount | (66,374) | (229,954) |
Less issuance cost | (55,292) | (129,408) |
Total, net of discount | $ 185,458 | $ 536,063 |
Stockholders' Equity (Details N
Stockholders' Equity (Details Narrative) - USD ($) | Nov. 20, 2020 | Nov. 18, 2020 | Nov. 17, 2020 | Nov. 12, 2020 | Nov. 09, 2020 | Nov. 05, 2020 | Oct. 22, 2020 | May 26, 2020 | May 21, 2020 | Feb. 19, 2020 | Dec. 16, 2019 | Mar. 31, 2021 | Jan. 31, 2021 | Mar. 31, 2021 | Mar. 31, 2020 | Dec. 31, 2020 |
Reverse stock split | 5-for-8 | 78.209 to effectuate a 5-for-8 reverse stock split | 1-for-20 | 78.209 to effectuate a 1-for-20 reverse stock split | ||||||||||||
Common stock, shares authorized | 125,000,000 | 125,000,000 | 125,000,000 | |||||||||||||
Number of shares of reverse stock split | 133 | |||||||||||||||
Payments for offering costs | $ 1,180,000 | |||||||||||||||
Issued shares of common stock to consultants for services, value | $ 221,250 | $ 38,000 | ||||||||||||||
Issued shares of common stock conversion of notes payable | 388,684 | |||||||||||||||
Issued shares of common stock conversion of notes payable, value | $ 1,243,788 | $ 1,243,788 | ||||||||||||||
Issued shares of common stock exercise of options | 77,444 | |||||||||||||||
Issued shares of common stock exercise of options, value | $ 246,278 | $ 246,278 | ||||||||||||||
Issued shares of common stock exercise of warrants | 39,095 | |||||||||||||||
Issued shares of common stock exercise of warrants, value | $ 123,562 | |||||||||||||||
Cashless warrant exercise, shares | 91,709 | |||||||||||||||
Cashless unit purchase option exercise, shares | 86,529 | |||||||||||||||
2019 Stock Incentive Plan [Member] | ||||||||||||||||
Issued shares of common stock to employees | 30,000 | |||||||||||||||
Issued shares of common stock to employees, value | $ 97,453 | |||||||||||||||
Issued shares of common stock to consultants for services | 71,500 | |||||||||||||||
Issued shares of common stock to consultants for services, value | $ 221,250 | |||||||||||||||
Underwriting Agreement [Member] | ||||||||||||||||
Number of shares issued for common stock | 3,625,000 | 3,625,000 | ||||||||||||||
Public offering price | $ 3.20 | |||||||||||||||
Purchase shares of common stock | 528,750 | |||||||||||||||
Proceeds from common stock | $ 1,500,000 | |||||||||||||||
Sale of stock, shares | 4,153,750 | |||||||||||||||
Proceeds from sale of stock | $ 11,800,000 | |||||||||||||||
Board of Directors [Member] | ||||||||||||||||
Reverse stock split | 5-for-8 | 1-for-20 | 1-for 5 and 1-for-25 | |||||||||||||
Common stock, shares authorized | 200,000,000 |
Equity-Based Compensation (Deta
Equity-Based Compensation (Details Narrative) - USD ($) | 3 Months Ended | 12 Months Ended | |||
Mar. 31, 2021 | Mar. 31, 2020 | Dec. 31, 2020 | Jan. 31, 2021 | Oct. 31, 2019 | |
Restricted stock vested shares | 24,445 | ||||
Options [Member] | |||||
Weighted average grant date fair value of options granted | $ 2.33 | ||||
Weighted average remaining service period | 3 years 8 months 12 days | ||||
Stock-based compensation expense | $ 376,524 | $ 381,475 | |||
Unamortized stock option expense | 2,642,796 | ||||
Restricted Stock and Restricted Stock Units [Member] | |||||
Stock-based compensation expense | $ 89,473 | $ 265,963 | |||
Number of shares of restricted stock issued | 30,000 | ||||
Restricted stock vesting period | 1 year | ||||
Restricted stock vested shares | 24,445 | ||||
Board of Directors [Member] | Minimum [Member] | |||||
Options life | 3 years | ||||
Board of Directors [Member] | Maximum [Member] | |||||
Options life | 10 years | ||||
2019 Stock Incentive Plan [Member] | |||||
Share based issuance of shares | 1,371,449 | 500,000 | |||
Number of available shares issuable | 578,356 | ||||
Share based payment arrangement, description | A provision in the 2019 Plan provides for an automatic annual increase equal to 6% of the total number of shares of Company common stock outstanding on December 31 of the preceding calendar year. In January 2020, the number of available shares was increased to 793,093. In January 2021, |
Equity-Based Compensation - Sch
Equity-Based Compensation - Schedule of Stock Options Activity (Details) - USD ($) | 1 Months Ended | 3 Months Ended | |
Mar. 31, 2021 | Mar. 31, 2021 | ||
Equity [Abstract] | |||
Number of Shares, Options Outstanding, Beginning balance | 594,114 | ||
Number of Shares, Options Outstanding, Forfeited | |||
Number of Shares, Options Outstanding, Vested | |||
Number of Shares, Options Outstanding, Exercised | 77,444 | ||
Number of Shares, Options Outstanding, Granted | 508,558 | ||
Number of Shares, Options Outstanding, Ending balance | 1,102,672 | 1,102,672 | |
Price per Share Range, Lower limit, Options Outstanding, Beginning balance | $ 3.19 | ||
Price per Share Range, Upper limit, Options Outstanding, Beginning balance | 9.25 | ||
Price per Share Range, Lower limit, Options Outstanding, Granted | 2.28 | ||
Price per Share Range, Upper limit, Options Outstanding, Granted | 2.55 | ||
Price per Share Range, Lower limit,Options Outstanding, Ending balance | 2.28 | ||
Price per Share Range, Upper limit, Options Outstanding, Ending balance | 9.25 | ||
Weighted Average Exercise Price, Options Outstanding, Beginning balance | 7.28 | ||
Weighted Average Exercise Price, Options Outstanding, Forfeited | |||
Weighted Average Exercise Price, Options Outstanding, Vested | |||
Weighted Average Exercise Price, Options Outstanding, Exercised | |||
Weighted Average Exercise Price, Options Outstanding, Granted | 2.33 | ||
Weighted Average Exercise Price, Options Outstanding, Ending balance | $ 4.33 | $ 4.33 | |
Aggregate Intrinsic Value, Options Outstanding, Beginning balance | [1] | ||
Aggregate Intrinsic Value, Options Outstanding, Ending balance | [1] | ||
Number of Shares, Options Exercisable, Beginning balance | 265,386 | ||
Number of Shares, Options Exercisable, Vested | 97,615 | ||
Number of Shares, Options Exercisable, Ending balance | 374,256 | 374,256 | |
Weighted Average Exercise Price, Options Exercisable, Beginning balance | $ 5.64 | ||
Weighted Average Exercise Price, Options Exercisable, Vested | 3.86 | ||
Weighted Average Exercise Price, Options Exercisable, Ending balance | $ 3.57 | $ 3.57 | |
Aggregate Intrinsic Value, Options Exercisable, Beginning balance | [1] | ||
Aggregate Intrinsic Value, Options Exercisable, Ending balance | [1] | ||
[1] | The intrinsic value of an option represents the amount by which the market value of the stock exceeds the exercise price of the option of in-the-money options only. |
Equity-Based Compensation - S_2
Equity-Based Compensation - Schedule of Share-based Payment Award, Stock Options, Valuation Assumptions (Details) | 3 Months Ended | |
Mar. 31, 2021 | Mar. 31, 2020 | |
Risk-free interest rate range, lower range | 0.22% | 0.48% |
Risk-free interest rate range, upper range | 0.31% | 1.65% |
Expected stock price volatility | 107.40% | |
Expected dividend yield | 0.00% | 0.00% |
Minimum [Member] | ||
Expected life of option-years | 5 years 6 months | 5 years 2 months 12 days |
Expected stock price volatility | 110.80% | |
Maximum [Member] | ||
Expected life of option-years | 6 years 6 months | 5 years 9 months 7 days |
Expected stock price volatility | 128.00% |
Equity-Based Compensation - S_3
Equity-Based Compensation - Schedule of Share Based Payments Arrangements Options Exercised and Options Vested (Details) - USD ($) | 3 Months Ended | 12 Months Ended |
Mar. 31, 2021 | Dec. 31, 2020 | |
Equity [Abstract] | ||
Total Intrinsic Value of Options Exercised | ||
Total Fair Value of Options Vested | $ 376,523 | $ 1,495,744 |
Equity-Based Compensation - S_4
Equity-Based Compensation - Schedule of Aggregate Restricted Stock Awards and Restricted Stock Unit Activity (Details) | 3 Months Ended |
Mar. 31, 2021USD ($)$ / sharesshares | |
Equity [Abstract] | |
Number of Unvested Shares, Beginning balance | shares | 16,698 |
Number of Unvested Shares, Granted | shares | 71,757 |
Number of Unvested Shares, Vested | shares | (24,445) |
Number of Unvested Shares, Forfeitures | shares | |
Number of Unvested Shares, Ending balance | shares | 64,010 |
Weighted Average Exercise Price, Beginning balance | $ / shares | $ 4.67 |
Weighted Average Exercise Price, Granted | $ / shares | 3.04 |
Weighted Average Exercise Price, Vested | $ / shares | 3.66 |
Weighted Average Exercise Price, Forfeitures | $ / shares | |
Weighted Average Exercise Price, Ending balance | $ / shares | $ 3.23 |
Aggregate Value of Unvested Shares, Beginning balance | $ | $ 77,927 |
Aggregate Value of Unvested Shares, Granted | $ | 218,228 |
Aggregate Value of Unvested Shares, Vested | $ | (89,473) |
Aggregate Value of Unvested Shares, Forfeitures | $ | |
Aggregate Value of Unvested Shares, Ending balance | $ | $ 206,682 |
Stock Options and Warrants (Det
Stock Options and Warrants (Details Narrative) - 2020 Convertible Notes Payable [Member] - USD ($) | 3 Months Ended | |
Mar. 31, 2021 | Jul. 01, 2020 | |
Proceeds from options | $ 247,821 | |
Proceeds from warrants | $ 125,104 | |
Purchase Agreements [Member] | Warrant [Member] | ||
Warrants to pruchase | 1 | |
Warrants exercise price | $ 3.20 | |
Warrants term | 5 years | |
Purchase Agreements [Member] | Warrant [Member] | Tribal Capital Markets, LLC [Member] | ||
Warrants to pruchase | 6,750 | |
Warrants exercise price | $ 3.20 | |
Warrants term | 5 years | |
Purchase Agreements [Member] | Purchase Options [Member] | ||
Unit options to purchase | 303,623 | |
Exercise price | $ 3.20 |
Stock Options and Warrants - Sc
Stock Options and Warrants - Schedule of Fair Value Measurement Inputs and Valuation Techniques (Details) | Mar. 31, 2021$ / shares |
Risk-free Interest Rate [Member] | Minimum [Member] | |
Warrants measurement input | 0.33 |
Risk-free Interest Rate [Member] | Maximum [Member] | |
Warrants measurement input | 0.39 |
Stock Price [Member] | Minimum [Member] | |
Stock Price | $ 3 |
Stock Price [Member] | Maximum [Member] | |
Stock Price | $ 3.95 |
Expected Life [Member] | |
Expected life of warrants and option (years) | 5 years |
Expected Stock Price Volatility [Member] | Minimum [Member] | |
Warrants measurement input | 108.2 |
Expected Stock Price Volatility [Member] | Maximum [Member] | |
Warrants measurement input | 112.5 |
Expected Dividend Yield [Member] | |
Warrants measurement input | 0 |
Income Taxes (Details Narrative
Income Taxes (Details Narrative) - USD ($) | 3 Months Ended | |
Mar. 31, 2021 | Mar. 31, 2020 | |
Income Tax Disclosure [Abstract] | ||
Income tax expense | ||
Income tax rate | 0.00% |
Commitments and Contingencies (
Commitments and Contingencies (Details Narrative) - USD ($) | Aug. 07, 2019 | Mar. 31, 2021 |
10% Senior Secured Convertible Promissory Notes [Member] | ||
Debt issuance date description | April 8, 2011 and November 9, 2011 | |
Interest rate | 10.00% | |
10% Senior Secured Convertible Promissory Notes [Member] | Investors [Member] | ||
Debt conversion description | Investors had the option to convert any unpaid principal and accrued interest into shares of Company's common stock original conversion prices of $0.96 and $0.32, respectively, subject to adjustments upon the Company's issuances of stock at prices less than the original conversion prices during the 24-months after issuance of each note (i.e., currently $0.2100). | |
Conversion price per share | $ 0.2100 | |
James Bowdring [Member] | Promissory Notes [Member] | ||
Repayments of debt | $ 65,197 |
Contracts With Customers (Detai
Contracts With Customers (Details Narrative) | Mar. 31, 2021USD ($) | Mar. 02, 2021USD ($)Number | Jan. 31, 2019USD ($) | Mar. 31, 2021USD ($) | Mar. 31, 2020USD ($) |
Licensing fee payment | $ 5,000,000 | ||||
Deferred revenues | $ 3,392,857 | $ 3,392,857 | $ 4,107,143 | ||
U.S. License and Distribution Agreement [Member] | Ferring International Center S.A [Member] | |||||
Initial upfront payment | $ 5,000,000 | ||||
Licensing fee payment | $ 3,000,000 | ||||
Recognization of income term | 7 years | ||||
Agreement description | Under the terms of the Distribution Agreement, Ferring completed its obligation to make an initial payment to the Company of $5,000,000 upon completion of the required closing conditions, including executed agreements from all current manufacturers of the Licensed Product that upon a material supply default by the Company, Ferring can assume a direct purchase relationship with such manufacturers. Ferring is obligated to make a second payment to the Company of $3,000,000 provided that the Company is successful in obtaining a five (5) day label enhancement from the FDA for the current incubation period for the Licensed Product at least three (3) years prior to the expiration of the term of the license for the Licensed Product and provided further that Ferring has not previously exercised its right to terminate the Distribution Agreement for convenience. In addition, the Company entered into a separate Distribution Agreement. | ||||
Agreement expiration date | Dec. 31, 2025 | ||||
Amendment [Member] | Ferring International Center S.A [Member] | |||||
Number of product purchased | Number | 2,004 | ||||
Purchase amount | $ 501,000 | ||||
Ferring License Agreement [Member] | |||||
Recognization of revenue | $ 178,571 |
Contracts With Customers - Sche
Contracts With Customers - Schedule of International Distribution Agreements (Details) | 3 Months Ended | |
Mar. 31, 2021 | ||
Canada [Member] | ||
Distribution Partner | Invaron Pharmaceuticals Inc. | |
Date | Jul. 31, 2020 | |
Initial Term | 1 year | |
INVOcell Registration Status In Country | Registered - Completed | |
Mexico [Member] | ||
Distribution Partner | Proveedora de Equipos y Productos S.A | [1] |
Date | Sep. 30, 2020 | |
Initial Term | 5 years | |
INVOcell Registration Status In Country | Registered - Completed | |
Malaysia [Member] | ||
Distribution Partner | iDS Medical Systems | |
Date | Nov. 30, 2020 | |
Initial Term | 3 years | |
INVOcell Registration Status In Country | Registered - Completed | |
Turkey [Member] | ||
Distribution Partner | Orcan Medical | |
Date | Oct. 31, 2019 | |
Initial Term | 1 year | |
INVOcell Registration Status In Country | Registered - Completed | |
Jordan [Member] | ||
Distribution Partner | Biovate | |
Date | Sep. 30, 2019 | |
Initial Term | 1 year | |
INVOcell Registration Status In Country | Registered - Completed | |
Pakistan [Member] | ||
Distribution Partner | Galaxy Pharma | |
Date | Dec. 31, 2020 | |
Initial Term | 1 year | |
INVOcell Registration Status In Country | In-process | |
Thailand [Member] | ||
Distribution Partner | IVF Envimed Co., Ltd. | |
Date | Apr. 30, 2021 | |
Initial Term | 1 year | |
INVOcell Registration Status In Country | In-process | |
Sudan [Member] | ||
Distribution Partner | Quality Medicines, Cosmetics & Medical Equipment Import | |
Date | Sep. 30, 2020 | |
Initial Term | 1 year | |
INVOcell Registration Status In Country | In-process | |
Ethiopia [Member] | ||
Distribution Partner | Quality Medicines, Cosmetics & Medical Equipment Import | |
Date | Sep. 30, 2021 | |
Initial Term | 1 year | |
INVOcell Registration Status In Country | In-process | |
Uganda [Member] | ||
Distribution Partner | Quality Medicines, Cosmetics & Medical Equipment Import | |
Date | Sep. 30, 2022 | |
Initial Term | 1 year | |
INVOcell Registration Status In Country | In-process | |
Nigeria [Member] | ||
Distribution Partner | G-Sytems Limited | |
Date | Sep. 30, 2023 | |
Initial Term | 1 year | |
INVOcell Registration Status In Country | In-process | |
Togolese Republic [Member] | ||
Distribution Partner | INVOSOLUX TOGO | |
Date | Nov. 30, 2019 | |
Initial Term | 1 year | |
INVOcell Registration Status In Country | In-process | |
Iran [Member] | ||
Distribution Partner | Tasnim Behboud | |
Date | Dec. 31, 2020 | |
Initial Term | 1 year | |
INVOcell Registration Status In Country | In-process | |
[1] | Also the JV Partner for Mexico |
Subsequent Events (Details Narr
Subsequent Events (Details Narrative) - shares | Apr. 09, 2021 | May 31, 2021 | Mar. 31, 2021 | Dec. 31, 2020 |
Common stock issued | 10,424,229 | 9,639,268 | ||
Subsequent Event [Member] | Partnership Agreement [Member] | Lyfe Medical Center I, LLC [Member] | ||||
Percentage of net income received | 40.00% | |||
Subsequent Event [Member] | 2019 Stock Incentive Plan [Member] | Consultant and Employee [Member] | ||||
Common stock issued | 24,806 |